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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 K901326
Device Name CHALLENGE 20 POWERED MUSCLE STIMULATOR
Applicant
Maximum Performance Technologies, Mpts, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact M HOLSTEIN
Correspondent
Maximum Performance Technologies, Mpts, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact M HOLSTEIN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/21/1990
Decision Date 05/29/1990
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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