K213452 is an FDA 510(k) clearance for the GEMS-H. This device is classified as a Powered Exoskeleton (Class II - Special Controls, product code PHL).
Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on April 21, 2022, 177 days after receiving the submission on October 26, 2021.
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 | K213452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2021 |
| Decision Date | April 21, 2022 |
| Days to Decision | 177 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. |