FDA 510(k) Application Details - K092142

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K092142
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant SPORT-ELEC
141 RESEARCH DRIVE
COMPLIANCE DEPT.
HAMPTON, VA 23666 US
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Contact KIMBERLY JONES
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 07/15/2009
Decision Date 02/05/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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