CLA-2-85:OT:RR:NC:N1:112
Kin-Joe Sham
Vice President of R&D, Operations
OrthoCor Medical, Inc.
1000 Westgate Drive
Minneapolis, MN 55114
RE: The tariff classification of the OrthoCor Active Knee System from China
Dear Mr. Sham:
In your letter dated April 29, 2010, you requested a tariff classification ruling.
The item concerned is referred to as the OrthoCor Active Knee System. This therapeutic system consists of a multiple-use therapy delivery cuff, fifteen pairs of single use therapy pods (also known as OrthoPods) and an AC adapter used to recharge the internal batteries.
The multiple-use therapy delivery cuff resembles a knee wrap/brace. This knee cuff contains coils/electrical components that emit/generate a low pulsed electromagnetic field (PEMF). These electrical components are embedded between two layers of neoprene which make up the cuff. The pulsed electromagnetic field is stated to provide healing/therapeutic properties. In this case, the therapy delivery cuff is designed to be placed around an injured knee. The PEMF that is generated by the delivery cuff is used to treat postoperative pain and edema in superficial soft tissues.
The single use therapy pods are integral parts of the OrthoCor Active Knee System. The pods consist of electrical components within a plastic outer housing. These one time use items contain a heating element and other electrical components which allow them to act as the “On/Off” switch for the multiple-use therapy delivery cuff. The multiple-use therapy delivery cuff needs to have two pods inserted into its pod docking ports, in order to initiate treatment. The pods last for a specific amount of time. When they burn out, they turn off the system ending the therapy session. This enables a doctor to prescribe a specific amount of therapy sessions. One pair of pods equals one therapy session. The heat generated by the pods is used mainly as a tangible method of allowing the user to recognize that the therapy session is taking place. Once the heat stops, the patient knows that the session is over. The pods will be available through prescription only.
Per the FDA Section 510(K) premarket notification, K092044, mailed to OrthoCor on 12-18-09, the OrthoCor Active Knee System is intended to deposit athermal RF energy in superficial soft tissues. Its use would be recommended by a physician or chiropractor.
You suggest classification of the OrthoCor Active Knee System under HTS 9018.90.7560, which provides for “other” electro-medical instruments and appliances. To support your claim you cite New York Ruling Letters I85148 – 105, September 4, 2002, and I86679 – 105, October 15, 2002. The devices covered by those two ruling letters differ significantly from your product. The PEMF devices covered by those rulings are large, expensive devices that are designed to be installed in hospitals or clinics, the use of which is directed by a qualified medical professional. The Harmonized System Explanatory Note to Heading 9018 states that the heading covers instruments and appliances used only in professional practice (e.g. by doctors, surgeons, dentists, etc) to make a diagnosis or, to prevent or treat an illness, or to operate. Your device is designed to be worn by an individual, and is not used by a medical professional. This being the case, the OrthoCor Active Knee System would not be classified in Heading 9018.
The applicable subheading for the OrthoCor Active Knee System will be 8543.70.9650, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Electrical machines…: Other machines and apparatus: Other: Other: Other: Other.” The general rate of duty will be 2.6%.
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 World Wide Web at http://www.usitc.gov/tata/hts/.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Steven Pollichino at (646) 733-3008.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division