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FDA 510(k)

TENS/EMS device (GUSE01)

K-Number: K253896 · 2026-03-04

ApplicantGlobalcare Medical Technology Co., Ltd.
Decision Date2026-03-04
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS/EMS device (GUSE01) is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253896. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS/EMS device (GUSE01)?

TENS/EMS device (GUSE01) is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Globalcare Medical Technology Co., Ltd.. The 510(k) number is K253896.

When did TENS/EMS device (GUSE01) receive FDA 510(k) clearance?

TENS/EMS device (GUSE01) received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253896.

Who is the listed applicant for TENS/EMS device (GUSE01)?

The FDA 510(k) record lists Globalcare Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS/EMS device (GUSE01)?

The FDA product code for TENS/EMS device (GUSE01) is NUH.

Other records listing Globalcare Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250136Globalcare Blood Pressure Monitor (GUS610)K222160GUS610 Blood pressure monitorK192633GUS831 Compressor NebulizerK192609Globalcare Blood Pressure Monitor

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse MedicalK252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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