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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 K090632
Device Name COMPEX REHAB
Applicant
Chattanooga Group
1430 Decision St.
Vista,  CA  92081
Applicant Contact NORA C.R. YORK
Correspondent
Chattanooga Group
1430 Decision St.
Vista,  CA  92081
Correspondent Contact NORA C.R. YORK
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/09/2009
Decision Date 06/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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