Cleared Traditional

K253896 - TENS/EMS device (GUSE01) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253896 · Globalcare Medical Technology Co., Ltd. · Neurology device
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Mar 2026
Decision
89d
Days
Class 2
Risk

K253896 is an FDA 510(k) clearance for the TENS/EMS device (GUSE01). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Globalcare Medical Technology Co., Ltd. (Zhongshan City, CN). The FDA issued a Cleared decision on March 4, 2026 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Globalcare Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K253896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2025
Decision Date March 04, 2026
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 226
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K253896.
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · Shenzhen Jiantuo Electronics Co., Ltd. · Dec 2025
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K251958 · Dynapulse Medical · Dec 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · Hong Qiangxing (Shenzhen) Electronics Limited · Dec 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
K251856 · Everyway Medical Instruments Co.,Ltd · Nov 2025
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K243131 · Sigma Biomedical · Nov 2025