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FDA 510(k) Application Details - K202148
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K202148
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Fit-Pro Ltd.
7 Szabadsag Ter
Budapest 1054 HU
Other 510(k) Applications for this Company
Contact
Janos Papp
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2020
Decision Date
08/25/2021
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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