Decision on Application for Further Review of Protest No. 2704-8-002494.

HQ 085064 August 24, 1990 CLA-2:CO:R:C:G 085064 SR CATEGORY: Classification TARIFF NO.: 688.42 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. Dear Sir: 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 stimulators. FACTS: 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. ISSUE: Whether the merchandise at issue is classifiable as a medical electrical therapeutic device. -2- 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 office. 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. HOLDING: 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 -3- requirement of section 174.30(a), Customs Regulations. Sincerely, John Durant, Director Commercial Rulings Division