Cleared Traditional

TENS/EMS device (GUSE01)

K253896 · Globalcare Medical Technology Co., Ltd. · Neurology

Mar 2026

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K253896 is an FDA 510(k) clearance for the TENS/EMS device (GUSE01), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Globalcare Medical Technology Co., Ltd. (Zhongshan City, CN). The FDA issued a Cleared decision on March 4, 2026, 89 days after receiving the submission on December 5, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K253896 FDA.gov
FDA Decision	Cleared 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

Device Classification

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