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FDA 510(k) Application Details - K192746
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K192746
Device Name
Stimulator, Muscle, Powered
Applicant
MyoWorx Inc.
201-77 Westmount Road, Suite 201
Guelph N1H 5J1 CA
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Contact
Bert Oucharek
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
09/30/2019
Decision Date
10/19/2021
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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