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FDA 510(k), K143690, Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
FDA 510(k), K143690, Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
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510(K) Number: K143690
Device Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
Manufacturer: EKSO BIONICS, INC.
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 12/24/2014
Decision Date: 04/01/2016
Regulation Medical Specialty: Physical Medicine
Device Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
Manufacturer: EKSO BIONICS, INC.
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 12/24/2014
Decision Date: 04/01/2016
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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