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510(k) K213452

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

K213452 is an FDA 510(k) premarket notification submitted by Samsung Electronics Co., Ltd. for the device "GEMS-H". The FDA issued a decision of Substantially Equivalent on April 21, 2022. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Samsung Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Samsung Electronics Co., Ltd.

  • K242651 — GM85 (October 1, 2024)
  • K242478 — GF85 (models GF85-3P, GF85-SP) (September 19, 2024)
  • K240909 — Samsung ECG App v 1.3 (ECG) (August 2, 2024)
  • DEN230041 — Sleep Apnea Feature (February 6, 2024)
  • K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)
  • K222353 — GM85 (September 29, 2022)
  • K220175 — GM85 (April 21, 2022)
  • K211139 — CUBE Air Purifier (November 26, 2021)
  • K201560 — Auto Lung Nodule Detection (August 31, 2021)
  • K201168 — ECG Monitor App (August 4, 2020)

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)

FDA data resources