510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213452Substantially Equivalent

Gems-H

Samsung Electronics Co., Ltd., Suwon-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213452 is the FDA 510(k) clearance record for GEMS-H, a class II device, cleared for Samsung Electronics Co., Ltd. on under FDA product code PHL (Powered Exoskeleton). FDA's definition for product code PHL reads: "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". FDA records list 42 510(k) clearances for Samsung Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K213452.

Clearance record

Decision date
Received
(177 days to decision)
Product code
PHL Powered Exoskeleton
Regulation
21 CFR 890.3480
Device class
Class II
Review panel
Physical Medicine
Applicant
Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHL

Trailing 12 months
2 clearances under product code PHL in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260