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FDA 510(k), K162817, Noddle(TM)
FDA 510(k), K162817, Noddle(TM)
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510(K) Number: K162817
Device Name: Noddle(TM)
Manufacturer: IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC.
Device Classification Name: system, communication, powered
Regulation Number: 890.3710
Classification Product Code: ILQ
Date Received: 10/06/2016
Decision Date: 01/18/2017
Regulation Medical Specialty: Physical Medicine
Device Name: Noddle(TM)
Manufacturer: IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC.
Device Classification Name: system, communication, powered
Regulation Number: 890.3710
Classification Product Code: ILQ
Date Received: 10/06/2016
Decision Date: 01/18/2017
Regulation Medical Specialty: Physical Medicine
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- 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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