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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 a medical device manufactured by Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-04 under approval 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. It is manufactured by Globalcare Medical Technology Co., Ltd.. The 510(k) number is K253896.

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

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

What company makes TENS/EMS device (GUSE01)?

TENS/EMS device (GUSE01) is manufactured by Globalcare Medical Technology Co., Ltd..

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

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

Other Devices by Globalcare Medical Technology Co., Ltd.

K192633GUS831 Compressor Nebulizer K192609Globalcare Blood Pressure Monitor K222160GUS610 Blood pressure monitor K250136Globalcare Blood Pressure Monitor (GUS610)

Related Devices (Code: NUH)

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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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