FDA 510(k), K173530, Indego(R)
FDA 510(k), K173530, Indego(R)
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510(K) Number: K173530
Device Name: Indego(R)
Manufacturer: Parker-Hannifin Corporation
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 11/15/2017
Decision Date: 01/31/2018
Regulation Medical Specialty: Physical Medicine
Device Name: Indego(R)
Manufacturer: Parker-Hannifin Corporation
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 11/15/2017
Decision Date: 01/31/2018
Regulation Medical Specialty: Physical Medicine
- 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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