FDA 510(k), K213622, Cionic Neural Sleeve NS-100
FDA 510(k), K213622, Cionic Neural Sleeve NS-100
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510(K) Number: K213622
Device Name: Cionic Neural Sleeve NS-100
Manufacturer: CIONIC
Device Classification Name: Stimulator, Neuromuscular, External Functional
Regulation Number: 882.5810
Classification Product Code: GZI
Date Received: 11/16/2021
Decision Date: 02/14/2022
Regulation Medical Specialty: Neurology
Device Name: Cionic Neural Sleeve NS-100
Manufacturer: CIONIC
Device Classification Name: Stimulator, Neuromuscular, External Functional
Regulation Number: 882.5810
Classification Product Code: GZI
Date Received: 11/16/2021
Decision Date: 02/14/2022
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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