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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 K902513
Device Name CHALLENGE 6010 POWERED MUSCLE STIMULATOR
Applicant
Maximum Performance Technologies, Mpts, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Maximum Performance Technologies, Mpts, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/05/1990
Decision Date 08/31/1990
Decision Substantially Equivalent (SESE)
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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