510(k) K213452

GEMS-H by Samsung Electronics Co., Ltd. — Product Code PHL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 21, 2022
Date Received: October 26, 2021
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

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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Other clearances for product code PHL

K250904 — Atalante X (October 24, 2025)
K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) (March 12, 2025)
K233695 — Medical HAL Lower Limb Type (HAL-ML) (May 7, 2024)
K232077 — Atalante X (December 13, 2023)
K221696 — ReWalk P6.0 (March 2, 2023)
K221859 — Atalante (December 29, 2022)
K220988 — EksoNR (June 9, 2022)
K201473 — ExoAtlet-II (July 16, 2021)
K201559 — HAL for Medical Use(Lower Limb type) (October 2, 2020)
K201539 — Keeogo Dermoskeleton System (September 9, 2020)