TENS/EMS device (GUSE01)

FDA 510(k) K253896 · Globalcare Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK253896

Submission

Device name
TENS/EMS device (GUSE01)
Applicant
Globalcare Medical Technology Co., Ltd.
Zhongshan City, CN
Received
December 5, 2025
Decision date
March 4, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional Hivox Biotek, Inc.06/16/2026SE
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K253740Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional Hong Qiangxing (Shenzhen) Electronics Limited12/23/2025SE
K251958VEINOPLUS BackNUH · Traditional Dynapulse Medical12/23/2025SE
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional Bozhou Rongjian Medical Appliance Co., Ltd.11/24/2025SE
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special Everyway Medical Instruments Co.,Ltd11/21/2025SE
K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE
K251429OTC 4-Channel Rechargeable TENS UnitNUH · Special Changsha Anxiang Medical Technology Co., Ltd.08/28/2025SE

More from Changsha Anxiang Medical Technology Co., Ltd.

510(k)DeviceDecision
K250136Globalcare Blood Pressure Monitor (GUS610)DXN · Special 04/08/2025SE
K222160GUS610 Blood pressure monitorDXN · Traditional 11/22/2022SE
K192633GUS831 Compressor NebulizerCAF · Traditional 05/01/2020SE
K192609Globalcare Blood Pressure MonitorDXN · Traditional 04/21/2020SE

Questions and answers

When was TENS/EMS device (GUSE01) cleared by the FDA?

TENS/EMS device (GUSE01) (K253896) received a 510(k) decision of Substantially Equivalent on March 4, 2026, 89 days after the submission was received.

What is the product code of K253896?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.