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FDA 510(k) Application Details - K210174
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K210174
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Bemer INT. AG
Austrasse 15
Triesen 9495 LI
Other 510(k) Applications for this Company
Contact
Sandra Schwarzenberger
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
01/22/2021
Decision Date
02/04/2021
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
Y
Expedited Review
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