FDA 510(k) Application Details - K133225

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

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510(K) Number K133225
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant FIT-PRO KFT LTD.
144 RESEARCH DRIVE
HAMPTON, VA 23666 US
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Contact RHONDA ALEXANDER, M.S., M.P.A.
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 10/21/2013
Decision Date 10/24/2014
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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