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FDA 510(k) Application Details - K211942
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K211942
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Shenzhen OSTO Technology Company Limited
No.43 Longfeng Road, Xinsheng Community, Longgang Street,
Longgang District
Shenzhen 518116 CN
Other 510(k) Applications for this Company
Contact
Li Yang
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
06/23/2021
Decision Date
12/13/2021
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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