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FDA 510(k) Application Details - K211298
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K211298
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Medical Cables S.L.
Calle Ferrocarril del Puerto 18 - Oficina 3-4
Mßlaga 29002 ES
Other 510(k) Applications for this Company
Contact
JosΘ Fuertes Pe±a
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
04/28/2021
Decision Date
08/25/2022
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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