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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K871472
Device Name KINESTIM MUSCLE STIMULATOR
Applicant
Promatek Industries, Ltd.
8390 Mayrand, Montreal
Quebec, H4p 2c9,  CA
Applicant Contact ART LEVINE
Correspondent
Promatek Industries, Ltd.
8390 Mayrand, Montreal
Quebec, H4p 2c9,  CA
Correspondent Contact ART LEVINE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/14/1987
Decision Date 06/29/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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