Gems-H
FDA 510(k) K213452 · Samsung Electronics Co., Ltd.
510(k) numberK213452
Submission
- Device name
- Gems-H
- Applicant
- Samsung Electronics Co., Ltd.
Suwon-Si, KR - Received
- October 26, 2021
- Decision date
- April 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHL – Powered Exoskeleton
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3480
- Specialty
- Physical Medicine
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.
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| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005)PHL · Traditional | Rewalk Robotics Ltd. Dba Lifeward | 03/12/2025SE |
| K233695 | Medical HAL Lower Limb Type (HAL-ML)PHL · Traditional | Cyberdyne, Inc. | 05/07/2024SE |
| K232077 | Atalante XPHL · Traditional | Wandercraft SAS | 12/13/2023SE |
| K221696 | ReWalk P6.0PHL · Traditional | Re Walk Robotics , Ltd. | 03/02/2023SE |
| K221859 | AtalantePHL · Traditional | Wandercraft SAS | 12/29/2022SE |
| K220988 | EksoNRPHL · Traditional | Ekso Bionics, Inc. | 06/09/2022SE |
| K201473 | ExoAtlet-IIPHL · Traditional | Exoatlet Asia Co. , Ltd. | 07/16/2021SE |
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Questions and answers
When was Gems-H cleared by the FDA?
Gems-H (K213452) received a 510(k) decision of Substantially Equivalent on April 21, 2022, 177 days after the submission was received.
What is the product code of K213452?
The FDA product code is PHL – Powered Exoskeleton, a Class II (moderate risk) device regulated under 21 CFR 890.3480.