CLA-2:CO:R:C:G 085064 SR
District Director of Customs
300 N. Los Angeles Street
Los Angeles, California 90012
RE: Decision on Application for Further Review of
Protest No. 2704-8-002494.
This protest was filed against your decision in the
liquidation on June 10, 1988, of entry number 110-0288073-7,
dated April 29, 1988, covering a shipment of Tenzcare
The merchandise at issue is the Tenzcare stimulator. It is
an electrical device which relieves pain through the use of
electrical nerve stimulation. It is believed to work by either
blocking, by electrical stimulation, the pain signal from being
carried by the nerve to the brain, or by activating the body's
mechanism which activates the production of endomorphins in the
brain which act as pain suppressors. The device is regulated by
the Food and Drug Administration and is available to the patient
only by means of a doctor's prescription. After receiving the
prescription, the patient purchases or leases the unit from a
medical equipment dealer. The use of the device is coordinated
under the doctor's review.
Whether the merchandise at issue is classifiable as a
medical electrical therapeutic device.
LAW AND ANALYSIS:
Item 709.17, TSUS, provides for medical instruments and
apparatus (including electro-medical apparatus and ophthalmic
instruments), and parts thereof, electro-medical apparatus, and
parts thereof, other, other. Item 688.42, TSUS, provides for
electrical articles and parts of articles, not specially provided
for, other, other.
The Tenzcare is not classifiable as a medical instrument or
apparatus. It is not used in a professional practice for
diagnosis, prevention or treatment of diseases, the correction of
deformities and defects, or the repair of injuries. The Tenzcare
is used by the patient at home, it is not used in the doctor's
The fact that Tenzcare is classified as a medical device by
the FDA has no binding effect on classification by Customs. "It
is well established that statutes, regulations and administrative
interpretations relating to "other than tariff purposes" are not
determinative of customs classification disputes." Amersham
Corp. v. United States, 5 CIT 49 at p. 56 (1983). Articles are
classified by the FDA to protect public safety, not as guidance
to customs classification.
Headquarters Ruling Letter 075124 dated June 14, 1985, dealt
with arm slings that were classified as a prosthetic article by
the FDA. Customs ruled that these slings were not classifiable
as orthopedic devices or prosthetic articles under item 709,
TSUS, even though they were classified as such by the FDA.
The merchandise at issue is classifiable under item 688.42,
TSUS, which provides for electrical articles not specially
provided for, other, other, other.
The protest should be denied. A copy of this decision should be
attached to the Form 19 Notice of Action to satisfy the notice
requirement of section 174.30(a), Customs Regulations.
John Durant, Director
Commercial Rulings Division