Cleared Traditional

K213452 - GEMS-H (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K213452 · Samsung Electronics Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
177d
Days
Class 2
Risk

K213452 is an FDA 510(k) clearance for the GEMS-H. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on April 21, 2022 after a review of 177 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.3480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Samsung Electronics Co., Ltd. devices

Submission Details

510(k) Number K213452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2021
Decision Date April 21, 2022
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 148d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PHL Powered Exoskeleton
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3480
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Mdlab, Inc.
Kyoungju Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04285060 Unknown Interventional Industry-sponsored

Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke

Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study

100
Patients (est.)
1
Site
Other
Purpose
Open label
Masking
Condition studied Stroke; Chronic Stroke
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Samsung Electronics (industry)
Started 2020-02-12 → Primary completion 2021-11-01 → Completed 2021-12-01
Primary outcome
Incidence of device related adverse events
Secondary outcome
6 Minute Walk Test (6MWT)
View full study on ClinicalTrials.gov