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FDA 510(k), K171909, HAL for Medical Use (Lower Limb Type)
FDA 510(k), K171909, HAL for Medical Use (Lower Limb Type)
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510(K) Number: K171909
Device Name: HAL for Medical Use (Lower Limb Type)
Manufacturer: CYBERDYNE Inc.
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 06/26/2017
Decision Date: 12/17/2017
Regulation Medical Specialty: Physical Medicine
Device Name: HAL for Medical Use (Lower Limb Type)
Manufacturer: CYBERDYNE Inc.
Device Classification Name: powered exoskeleton
Regulation Number: 890.3480
Classification Product Code: PHL
Date Received: 06/26/2017
Decision Date: 12/17/2017
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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