Import Alert 89-06
-
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 89-06
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of 'Super Pulse' Electronic Devices"
Reason for Alert:
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The 510(k) premarket notification was withdrawn by CDRH on March 8, 1986 for failure to provide additional information.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.
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The 510(k) premarket notification was withdrawn by CDRH on March 8, 1986 for failure to provide additional information.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:
Districts may detain, without physical examination, all "SUPER PULSE" and similar electronic transcutaneous devices shipped from Toyoda Tsushio Kaisha Ltd., Tokyo, Japan and/or Cosmo-Sonic, Inc, Tokyo, Japan,
Product Description:
Super Pulse electronic devices
Charge:
"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)."
OASIS charge code - NO 510(K)
OASIS charge code - NO 510(K)
JAPAN
Cosmo Sonic Inc
Date Published : 09/16/2009
1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN
89 - - - -- Physical Medicine
Date Published: 09/16/2009
Toyota Tsusho Corporation
Date Published : 09/16/2009
3-18, Kudan-Minami, 2-Chome, Chiyoda-Ku , Tokyo, JAPAN
89 - - - -- Physical Medicine
Date Published: 09/16/2009
-
