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FDA 510(k) Application Details - K152480
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K152480
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
Angela Glover
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
08/31/2015
Decision Date
03/31/2016
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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