The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gems-h.
| Device ID | K213452 |
| 510k Number | K213452 |
| Device Name: | GEMS-H |
| Classification | Powered Exoskeleton |
| Applicant | Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
| Contact | Minhyung Lee |
| Correspondent | Kyoungju Kim MDLab Inc. Room 804, 161-17, Magokjungang-ro, Gangseo-gu Seoul, KR 07788 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-26 |
| Decision Date | 2022-04-21 |