HQ H265244
CLA-2 OT:RR:CTF:TCM H265244 TSM
Mr. Joseph Johnson
Total Comfort Medical
21200 S La Grange Road, Suite 134
Frankfort, Il 60423
RE: Reconsideration of HQ H261835; tariff classification of certain knee protectors
Dear Mr. Johnson,
This is in response to Headquarters Ruling Letter (HQ) H261835, dated May 18, 2015, which concerned the tariff classification under the Harmonized Tariff Schedule of the United States (HTSUS) of certain imported knee protectors. For the reasons set forth below, we are revoking HQ H261835.
FACTS:
The subject merchandise consists of knee protectors which help support and protect the knees of patients who have undergone total knee arthroplasty surgery. They are designed to wrap around a person’s knee with hook and loop fastener straps that secure them to the user. The front of the knee protectors is made from nylon knit neoprene fabric, while the back is made from nylon/spandex knit fabric, which is breathable, moisture-wicking and soft. The knee protectors also have an inner core, which is a foam padding made of two separate foam layers that are laminated together. The first layer, which measures 3/8 of an inch thick, is made of urethane, and the second layer, which measures 5/8 of an inch thick, is made of nitrile polyvinyl chloride (PVC) and butadiene rubber (NBR).
You state that the knee protectors are specially designed to aid in the knee replacement recovery process in the following ways: (1) Support for the knee area when completing physical therapy rehabilitation following total knee replacement surgery (the dual layer foam technology incorporated into the knee protector provides support and protection for the knee, with the first, open cell urethane layer, custom contouring to the knee for customized supportive fit, and the second, closed cell PVC/NBR layer, further eliminating pressure and discomfort due to its energy-absorbing qualities); (2) Protection of the knee area from unexpected impacts following a total knee replacement surgery (the wrap-around feature of the knee protector offers 360° of protection around the knee and a curved strap helps to eliminate pinching behind the leg); and (3) Support for knee area to prevent further damage or irritation following a knee injury or illness (the knee protectors have also been designed to prevent and alleviate conditions such as diabetic knee ulcers, pressure sores or an inflamed knee bursa). You also provided evidence showing that an application to classify the subject knee protectors as class 1 medical devices is currently pending before the Food and Drug Administration (“FDA”).
A sample of the subject merchandise was received and examined by this office. The sample, images of which are displayed below, is being returned to you.
ISSUE:
What is the proper tariff classification of the knee protectors under consideration?
LAW AND ANALYSIS:
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order.
In addition, in interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).
The HTSUS provisions under consideration are as follows:
3926 Other articles of plastics and articles of other materials of headings 3901 to 3914:
3926.20 Articles of apparel and clothing accessories (including gloves, mittens and mitts:
Other:
3926.20.90 Other.
* * *
3926.90 Other
3926.90.99 Other
* * *
6307 Other made up articles, including dress patterns:
6307.90 Other:
Other:
6307.90.98 Other.
* * *
9021 Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:
9021.10.00 Orthopedic or fracture appliances, and parts and accessories thereof.
In your ruling request, you argued that the knee protectors at issue are classified in heading 9021, HTSUS, which covers, in pertinent part, orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; parts and accessories thereof. In support of this argument, you stated that the subject knee protectors are designed specifically for use by patients who have undergone a total knee replacement surgery. Specifically, you argue that the knee protectors are designed to aid in the following ways: (1) provide support for the knee area when completing physical therapy rehabilitation; (2) provide protection for the knee area from unexpected impacts; and (3) provide support for the knee area to prevent further damage or irritation.
You also provided evidence showing that an application to classify the subject knee protectors as class 1 medical devices is currently pending before the FDA. In this regard, we note that articles are classified by the FDA to protect public safety, not as guidance for classification of imported merchandise. See Amersham Corp. v. United States, 5 C.I.T. 49, 56, 564 F.Supp. 813, 817 (1983) (Noting that “statutes, regulations and administrative interpretations relating to ‘other than tariff purposes’ are not determinative of [CBP] classification disputes.”); see also HQ 085064, dated August 24, 1990 and HQ 962181, dated January 13, 1999. Recognition by the FDA that the subject merchandise can be used to support or protect the knee does not constitute a determination of its tariff classification.
To determine whether the subject knee protectors are classified in heading 9021, HTSUS, we first consider whether they are “orthopedic appliances” within the meaning of Note 6 to Chapter 90, which provides as follows:
For the purposes of heading 9021, the expression “orthopedic appliances” means appliances for:
Preventing or correcting bodily deformities; or
Supporting or holding parts of the body following an illness, operation or injury.
Orthopedic appliances include footwear and special insoles designed to correct orthopedic conditions, provided that they are either (1) made to measure or (2) mass-produced, entered singly and not in pairs and designed to fit either foot equally.
The ENs to heading 9021 state, in pertinent part, the following:
Orthopaedic appliances are defined in Note 6 to this Chapter. These are appliances for :
- Preventing or correcting bodily deformities; or
- Supporting or holding parts of the body following an illness, operation or injury.
They include:
Appliances for hip diseases (coxalgia, etc.).
Humerus splints (to enable use of an arm after resection), (extension splints).
Appliances for the jaw.
Traction, etc., appliances for the fingers.
Appliances for treating Pott’s disease (straightening head and spine).
Orthopaedic footwear and special insoles designed to correct orthopaedic conditions, provided that they are either (1) made to measure or (2) mass-produced, presented singly and not in pairs and designed to fit either foot equally.
Dental appliances for correcting deformities of the teeth (braces, rings, etc.).
Orthopaedic foot appliances (talipes appliances, leg braces, with or without spring support for the foot, surgical boots, etc.).
Trusses (inguinal, crural, umbilical, etc., trusses) and rupture appliances.
Appliances for correcting scoliosis and curvature of the spine as well as all medical or surgical corsets and belts (including certain supporting belts) characterised by:
Special pads, springs, etc., adjustable to fit the patient.
The materials of which they are made (leather, metal, plastics, etc.);
or
The presence of reinforced parts, rigid pieces of fabric or bands of various widths.
The special design of these articles for a particular orthopaedic purpose distinguishes them from ordinary corsets and belts, whether or not the latter also serve to support or hold.
Orthopaedic suspenders (other than simple suspenders of knitted, netted or crocheted materials, etc.).
With regard to splints and other fracture appliances, the ENs to heading 9021 further
state, in pertinent part, the following:
Fracture appliances are used either to immobilise injured parts of the body (for extension or protection), or for setting fractures. They are also used in the treatment of dislocations and other joint injuries.
According to Taber’s Cyclopedic Medical Dictionary, Edition 15, 1985, orthopedic is defined as “concerning orthopedics; prevention or correction of deformities.” A deformity is defined by Taber’s Cyclopedic Medical Dictionary as “an alteration in the natural form of a part or organ. Distortion of any part or general disfigurement of the body. It may be acquired or congenital. If present after injury, usually implies the presence of fracture, dislocation or both. May be due to extensive swelling, extravasation of blood or rupture of muscles.”
Upon review, we find that the knee protectors under consideration here do not “prevent or correct bodily deformities” within the meaning Note 6 to Chapter 90, HTSUS. Although you assert that the subject knee protectors are designed to provide protection and support for the knee area following a knee replacement surgery, we find that they are not “ejusdem generis” or “of the same kind” of merchandise as orthopedic appliances listed in heading 9021, HTSUS. In this regard, we note that the knee protectors at issue are not similar to any of the exemplars covered by the ENs to heading 9021, HTSUS. Moreover, we further note that the subject knee protectors are also not akin to splints and other fracture appliances of heading 9021, which, as the ENs to heading 9021 provide, may be used either to immobilize injured parts of the body or to set fractures.
In conformity with the above, it has consistently been our position that only devices designed to immobilize injured body parts are classified in heading 9021, HTSUS. See, NY N235435, dated December 12, 2012 (classifying a knee device with range of motion hinges and a locking joint for positioning the knee in either a flexion or extension position in heading 9021, HTSUS); and HQ 958190, dated September 5, 1995, (classifying a neoprene wrist support containing permanently inserted, rigid plastic support bars that were designed to immobilize the wrist in order to relieve tendinitis and prevent recurrence of carpal tunnel syndrome in heading 9021, HTSUS). See also, HQ 964317, dated May 1, 2001 (a knee brace made of 90 percent neoprene and 10 percent nylon or polyester and elastic with two hinged metal braces would be excluded from classification in heading 9021 because it does not immobilize the knee).
In accordance with the foregoing, we find that since the subject knee protectors are not “ejusdem generis” with the orthopedic appliances provided for in heading 9021, HTSUS, they are not classified in this heading.
As discussed above, the knee protectors under consideration are composed of knit fabric, specifically nylon neoprene and nylon spandex, as well as foam padding consisting of two layers laminated together – the first one made of urethane and the second one made of PVC/NBR. In this regard, GRI 2(b) states, in pertinent part, that the classification of goods consisting of more than one material or substance shall be according to the principles of GRI 3.
GRI 3 states that, when goods are prima facie classifiable under two or more headings, classification shall be effected as follows:
(a) ...when two or more headings each refer to
part only of the materials or substances
contained in mixed or composite goods…
those headings are to be regarded as
equally specific in relation to those goods,
even if one of them gives a more complete
or precise description of the goods.
(b) Mixtures, composite goods consisting of
different materials or made up of different components,...which cannot be classified by
reference to 3(a), shall be classified as if
they consisted of the material or component
which gives them their essential character,
insofar as this criterion is applicable.
Inasmuch as the instant merchandise qualifies as a composite good with separable components, it must be classified accordingly. If imported alone, the textile portion of the article would be classified in heading 6307, HTSUS, which provides for other made up articles of textile. The foam padding portion, composed of urethane, PVC and NBR, if imported separately, would be classified in heading 3926, HTSUS, which provides for other articles of plastics and articles of other materials of headings 3901 to 3914, HTSUS.
Under GRI 3(b), the merchandise must be classified as if it consisted of the component which gives the merchandise its essential character. The term "essential character" is not defined within the HTSUS, GRIs or ENs. EN VIII to GRI 3(b), gives guidance, stating that:
[T]he factor which determines essential character will vary as between different kinds of goods. It may, for example, be determined by the nature of the material or component, its bulk, quantity, weight or value, or by the role of a constituent material in relation to the use of the goods.
The courts have discussed the issue of classification by application of GRI 3(b) on several occasions. See Conair Corp. v. United States, 29 C.I.T. 888 (2005); Structural Industries v. United States, 360 F. Supp. 2d 1330, 1337-1338 (Ct. Int’l Trade 2005); and Home Depot USA, Inc. v. United States, 427 F. Supp. 2d 1278, 1295-1356 (Ct. Int’l Trade 2006), aff’d 491 F.3d 1334 (Fed. Cir. 2007). In particular, in Home Depot USA, Inc. v. United States, the court stated “[a]n essential character inquiry requires a fact intensive analysis.” 427 F. Supp. 2d 1278, 1284 (Ct. Int’l Trade 2006). In that case, the Court of International Trade examined all of the factors listed in EN VIII to GRI 3(b) to determine the classification of merchandise. Id. at 1293. In addition, the court also noted that the EN list is not exhaustive and that other factors should be considered including the article’s name, primary function, and the “attribute which strongly marks or serves to distinguish what it is. Its essential character is that which is indispensable to the structure, core or condition of the article, i.e., what it is.” Id. (quoting A.N. Deringer, Inc. v. United States, 66 Cust. Ct. 378 (1971)). CBP finds that an essential character analysis will vary from product to product.
In the instant case, we have not been provided with information on the value of the components and note that neither the weight, bulk, nor quantity of the components is determinative of the essential character of the merchandise. Accordingly, the role of the foam padding component in relation to the use of the knee protectors is the most significant factor. Without the foam padding component, the knee protectors would not provide the support and protection to the knee area, as described above. Therefore, the essential character of the subject knee protectors is imparted by the foam padding.
In accordance with GRI 3(b), we find that the foam padding component of the subject knee protectors imparts their essential character. Accordingly, the knee protectors are classified in subheading 3926.90.99, HTSUS, which provides for “Other articles of plastics and materials of headings 3901 to 3914: Other: Other.” Although in HQ H261835 we concluded that the subject knee protectors are classified in subheading 3926.20.90, HTSUS, upon further review we find this classification to be erroneous. Since subheading 3926.20, HTSUS, is limited solely to “Articles of apparel and clothing accessories (including gloves, mittens and mitts),” we find that the subject knee protectors are not classified in this subheading. See NY L83443, dated April 11, 2005.
HOLDING:
By application of GRI 3(b), we find that the subject merchandise is classified in subheading 3926.90.99, HTSUS, as “Other articles of plastics and materials of headings 3901 to 3914: Other: Other.” The 2015 column one, general rate of duty is 5.3 percent ad valorem.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the internet at www.usitc.gov/tata/hts/. A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the CBP officer handling the transaction.
EFFECT ON OTHER RULINGS:
HQ H261835, dated May 18, 2015, is hereby revoked. This revocation is not subject to the notice and comment provisions of 19 U.S.C. § 1625(c) because HQ H261835 has been in effect for less than 60 days.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division