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FDA 510(k) Application Details - K213197
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K213197
Device Name
Stimulator, Muscle, Powered
Applicant
Thought Technology Ltd.
5250 Ferrier, Suite 812
Montreal H4P 1L3 CA
Other 510(k) Applications for this Company
Contact
Suresh Sugirtharaja
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
09/29/2021
Decision Date
06/17/2022
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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