510(k) K171909
K171909 is an FDA 510(k) premarket notification submitted by Cyberdyne, Inc. for the device "HAL for Medical Use (Lower Limb Type)". The FDA issued a decision of Substantially Equivalent on Dec 17, 2017. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Cyberdyne, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2017
- Date Received
- Jun 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Exoskeleton
- Device Class
- Class II
- Regulation Number
- 890.3480
- Review Panel
- NE
- Submission Type
- 510(k)
A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.