K233695 is an FDA 510(k) clearance for the Medical HAL Lower Limb Type (HAL-ML). This device is classified as a Powered Exoskeleton (Class II - Special Controls, product code PHL).
Submitted by Cyberdyne, Inc. (Tsukuba, JP). The FDA issued a Cleared decision on May 7, 2024, 172 days after receiving the submission on November 17, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.3480. 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..
| 510(k) Number | K233695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2023 |
| Decision Date | May 07, 2024 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PHL - Powered Exoskeleton |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3480 |
| Definition | 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. |