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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, For Muscle Conditioning
510(k) Number K031611
Device Name P4-FITNESS
Applicant
Valmed Corp.
5080 N. Ocean Dr. 1a
Singer Island,  FL  33404
Applicant Contact GUY POITOUT
Correspondent
Valmed Corp.
5080 N. Ocean Dr. 1a
Singer Island,  FL  33404
Correspondent Contact GUY POITOUT
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/22/2003
Decision Date 09/29/2004
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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