Cleared Traditional

K192201 - Electrical Stimulator System

K192201 is an FDA 510(k) clearance for Electrical Stimulator System, manufactured by Gymmax Technology Shenzen Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K192201 · Gymmax Technology Shenzen Co., Ltd. · Neurology device
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Jun 2020
Decision
304d
Days
Class 2
Risk

K192201 is an FDA 510(k) clearance for the Electrical Stimulator System. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Gymmax Technology Shenzen Co., Ltd. (Shenzhen City, CN). The FDA issued a Cleared decision on June 12, 2020 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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. Elevated predicate reliance profile. 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 Gymmax Technology Shenzen Co., Ltd. devices

FDA 510(k) Submission Details - K192201

510(k) Number K192201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2019
Decision Date June 12, 2020
Days to Decision 304 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
156d slower than avg
Panel avg: 148d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Imd Medical & Drug Technology Service Institutions
Salon Chen

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.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 157
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K192201.
StimPlus Patch, StimPlus Patch, StimPlus Patch
K200561 · Jkh Health Co., Ltd. · Jul 2020
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K200354 · Shenzhen Dongjilian Electronics Co., Ltd. · Jun 2020
TENS and Muscle Stimulator
K200727 · Shenzhen Astec Technology Co., Ltd. · Jun 2020
LIVIA
K183110 · Lifecare , Ltd. · May 2020
Health Expert Electronic Stimulator (model: AST-300L)
K190783 · Shenzhen Osto Technology Company Limited · Mar 2020
Everyway OTC TENS/EMS Combination
K192589 · Everyway Medical Instruments Co.,Ltd · Dec 2019