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FDA 510(k) Application Details - K192887
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K192887
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Actegy, Ltd.
Reflex, Cain Road
Bracknell RG12 1HL GB
Other 510(k) Applications for this Company
Contact
Lawrence Brookfield
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
10/10/2019
Decision Date
05/04/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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