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FDA 510(k), K160614, Xcite Clinical Station
FDA 510(k), K160614, Xcite Clinical Station
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510(K) Number: K160614
Device Name: Xcite Clinical Station
Manufacturer: Andrew Barriskill
Device Classification Name: Stimulator, Muscle, Powered
Regulation Number: IPF
Classification Product Code: KXA
Date Received: 03/03/2016
Decision Date: 12/16/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
Device Name: Xcite Clinical Station
Manufacturer: Andrew Barriskill
Device Classification Name: Stimulator, Muscle, Powered
Regulation Number: IPF
Classification Product Code: KXA
Date Received: 03/03/2016
Decision Date: 12/16/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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