FDA 510(k) Application Details - K212832

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K212832
Device Name	Stimulator, Muscle, Powered
Applicant	TimeWaver Production GmbH Schloss Kraenzlin, Darritzer Strass 6 Kraenzlin 16818 DE Other 510(k) Applications for this Company
Contact	Babak Jafarian Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2021
Decision Date	12/14/2021
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