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FDA 510(k), K160987, ReWalk(TM)
FDA 510(k), K160987, ReWalk(TM)
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$149.00 USD
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$149.00 USD
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510(K) Number: K160987
Device Name: ReWalk(TM)
Manufacturer: REWALK ROBOTICS INC.
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 04/08/2016
Decision Date: 07/22/2016
Regulation Medical Specialty: Physical Medicine
Device Name: ReWalk(TM)
Manufacturer: REWALK ROBOTICS INC.
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 04/08/2016
Decision Date: 07/22/2016
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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