IA#89-06 --- 1/26/88
BACKGROUND
NYK-DO inspection has verified the continued marketing of the "SUPER PULSE"
Electrostatic Discharge Current Unit, an electrical nerve stimulator device
which is not covered by an effective Premarket Notification 510(k). The units
are manufactured by Toyoda Tsushio Kaisha, Ltd., 3-18 Kudanhname, 2-Chome
Chyoda-Ku, Tokyo 102, Japan, and imported by Toyoda America, Inc., New York,
NY, via Kintetsu World Express Inc. Toyoda America imports the device
exclusively for labeling and distribution by East West Scientific Corp.,
Greenvale, NY. The NYK investigation also revealed that Toyoda - Japan may be
using another name or shipping the units via Cosmo Sonic, Inc., 1-17, 4 Hongo,
Bunkyo-Ku, Tokyo, Japan.
The units are imported in bulk with the identifying name "SUPER PULSE" as the
only labeling. The units are often referred to as "Testers" on entry
documents, which present a problem in identifying the units as medical devices.
The 510(k) premarket notification was withdrawn by CDRH on March 8, 1986 for
failure to provide additional information. East West's continued marketing of
the device has resulted in a seizure of 120 units and the issuance of a
regulatory letter. The operation manual accompanying the "SUPER PULSE" makes
such claims as: promotes the rapid reduction of pain, reduces muscle
stiffness, and increases joint range of motion.
GUIDANCE
Automatically detain all "SUPER PULSE" and similar electronic transcutaneous
devices shipped from Toyoda Tsushio Kaisha Ltd., Tokyo, Japan and/or
Cosmo-Sonic, Inc, Tokyo, Japan, Charging:
"The article is subject to refusal of admission pursuant to Section 801(a)(3)
in that it appears to be misbranded within the meaning of Section 502(o) of
the Act in that the article is a medical device for which a premarketing
notice or other information respecting it was not provided as required by
Section 510(k)."
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