CLA-2-90:RR:NC:N1:105 I85148
Mr. Stephen S. Spraitzar
Three Embarcadero Center, Suite 1160
San Francisco, CA 94111
RE: The tariff classification of pulse electromagnetic field (PEMF) devices from Germany
Dear Mr. Spraitzar:
In your letter dated August 2, 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:
An Alphatron 4100 signal generator, which generates electrical impulses for use in PEMF (Pulse Electromagnetic Field) therapy. This device is specifically designed by Alphatron, the German manufacturer, to emit low-frequency energy for PEMF therapy.
An MF 550 mm air coil/bed unit. The air coil is fitted with special brackets so that it can be mounted and slide on the bed rails. In addition, the bed is specially designed for use with the air coil, in that the bed is configured with rails to allow the air coil to slide up and down the length of the bed. Thus, the air coil and specially designed bed are designed to be used as a unit.
The air coil itself consists 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, etc.) is placed for treatment. 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.
The air coil and specially designed bed would be sold as a unit and are imported together.”
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 similar 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 only uses indicated for the device are traditional goals of the medical sciences, i.e., and speeding healing and reducing pain.
Noting CAFC 00-1263, 8543.20 is not the best classification since it describes well only part of the import, while 9018 describes the entire import.
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 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,
National Commodity
Specialist Division