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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 K100862
Device Name BODYFLOW P2CH
Applicant
Physiomed Elektromedizin AG
Hutweide 10
Schnaittach/Laipersdorf,  DE D-91220
Applicant Contact BIRGIT SCHMID
Correspondent
Physiomed Elektromedizin AG
Hutweide 10
Schnaittach/Laipersdorf,  DE D-91220
Correspondent Contact BIRGIT SCHMID
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/29/2010
Decision Date 04/21/2011
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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