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NY I86679




October 15, 2002

CLA-2-90:RR:NC:N1:105 I86679

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.90.7560

Mr. Stephen S. Spraitzar
Three Embarcadero Center, Suite 1160
San Francisco, CA 94111

RE: The tariff classification of electromagnetic air coils from Germany

Dear Mr. Spraitzar:

In your letter dated September 19, 2002 for Sun America Group LLP, you requested a tariff classification ruling. No sample was submitted.

You state: “The merchandise that is the subject of this ruling request is manufactured in Germany and consists of the following four items:

Alphatron 315 mm air coil: This coil is manufactured by Alpha Electronics in Germany and is used in connection with “pulse electromagnetic field” (PEMF) therapy. Because it is specially designed and built with PEMF in mind, this coil is not a general purpose, off-the-shelf coil. The coil receives electromagnetic pulses from a specially designed PEMF signal generator. The function of the coil is to transform the electrical energy provided by the signal generator into magnetic energy so that it can be used for treatment on the affected area of the patient. Because of its smaller size, this coil is specifically utilized for treatment of the extremities (feet or hands). In operation, a patient will place his or her hands or feet inside the coil to receive the PEMF therapy. Attached as Exhibit 1 is a picture that depicts the 315 mm air coil.

Alphatron MF 500 mm air coil: This coil is imported separately (without a bed), and is also intended to be used for PEMF therapy. The function of this coil is the same as the 315 mm coil, except that the MF 500 mm air coil is larger than that of the 315 mm air coil. Thus, it is sufficiently large enough for a normal person (the torso) to fit inside this air coil. The 500 mm air coil is fitted with special brackets so that it can be mounted and slide on a specially made bed (imported separately) for use in PEMF therapy. Set forth as Exhibit 2 is a picture that depicts two PEMF air coils. The 500 mm air coil is the one in the upper left of the picture.

Both the 315 mm and 500 mm air coils are composed of 14 gauge copper wire, which is

Wound on a plastic spool, and thereafter encased in plastic. The term ‘air coil’ in the invoice
description refers to the hollow section into which the patient’s body (arm, leg, torso, etc.)
is placed for treatment.

A flat applicator with two wall arms: This is essentially an air coil, serves the same purpose as the 315 mm and 500 mm air coils, but is constructed differently. The flat applicator is used for obese patients who are unable to fit inside a 50 mm or 550 mm air coil. With the flat applicator, one arm is placed on one side (such as the chest) of the patient, and the other arm is placed on the other side of the patient (such as the back). Set forth as Exhibit 3 is a picture that depicts the flat applicator with two single wall arms.

D. 550 mm air coil with wall arm: This consists of a 550 mm air coil with a mechanism that allows the air coil to be mounted on and maneuvered from a wall. This mechanism permits the 550 mm air coil to be used without being mounted on the specially designed PEMF bed, which can be rather expensive. With the wall arm mechanism attached, the 550 mm air coil can be used with any hospital or therapy bed. Exhibit 4 depicts the 550 mm air coil with wall arm.”

As your information indicates, there are no known published journal articles demonstrating the effectiveness via clinical trials of pellet-like permanent magnets placed over specific parts of the body. However, there are positive clinical trials for the use of PEMF devices in speeding up the healing of certain bone fractures and there are on-going trials by recognized medical organizations for other possible uses, including pain management and speeding the healing of skin wounds.

The device is alternative medicine in that one would not expect to find one in the local hospital until, if ever, clinical trials establish its effectiveness for the wide range of medical uses being studied. However, noting the size and cost of the device, individual home use would likely be the exception, and the primary uses indicated for the device are traditional goals of the medical sciences, i.e., speeding, healing and reducing pain. You enclosed a flyer from the Long Island Pain Treatment Center which states that the patient’s rheumatoid arthritis is also one of the indication for the use of the device as a treatment. While it is clear that very few of those who have been trained in the Medical Sciences in accredited medical schools would agree with that, the same is also true of several claims made by traditional acupuncturists, and acupuncture needles are given as examples of medical instruments in Harmonized System Explanatory Note I-N to 90.18.

The air coils are the actual emitters of the signals which treat the patient so they have the essential character of full device, noting General Rule of Interpretation 2-a.

Your documentation states that the EMF emitted is non-ionizing and non-thermal so neither HTS 9022 nor 9018.20 applies.

Also, from that description, it appears the requirements for a FDA form FD 2877 for Electronic Products per Customs Regulation 12.91-b will not apply. See 21 CFR (the Food and Drug Administration Regulations), Chapter 1, Subchapter J (Radiological Health), Part 1000 (General).

We agree that, consistent with NYRL i85148, the applicable subheading for this device will be 9018.90.7560, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” therapeutic electro-medical instruments and appliances. The rate of duty will be free.

Specifically regarding items classified in 9018.90.7560, if the importer files the entries electronically, it will receive a message from Customs stating that FDA Notification 701 is required. If you wish to get more information regarding the FDA requirement and confirmation concerning the FD 2877, you should contact directly the U.S. Food and Drug Administration. Division of Small Manufacturer Assistance, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850. The Center’s 800 telephone number for its Small Manufacturer, International and Consumer Assistance is currently 800-638-2041.

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 J. Sheridan at 646-733-3012.

Sincerely,

Robert B. Swierupski
Director,

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