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FDA 510(k) Application Details - K133225
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
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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RHONDA ALEXANDER, M.S., M.P.A.
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NGX
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More FDA Info for this Product Code
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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