TENS/EMS device (GUSE01)— 510(k) K253896

Name: FDA 510(k) clearance K253896
Creator: U.S. Food and Drug Administration
Published: 2026-03-04

Substantially Equivalent

Globalcare Medical Technology Co., Ltd.

FDA 510(k) clearance K253896 for TENS/EMS device (GUSE01), Substantially Equivalent on 2026-03-04. Applicant: Globalcare Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Globalcare Medical Technology Co., Ltd.
Product code: Code NUH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2025-12-05
Decision date: 2026-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhongshan City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUH

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K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H)2026-06-26
K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)2026-06-16
K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)2025-12-31
K251958 — VEINOPLUS Back2025-12-23
K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D)2025-12-23

More clearances from Globalcare Medical Technology Co., Ltd.

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K250136 — Globalcare Blood Pressure Monitor (GUS610)2025-04-08
K222160 — GUS610 Blood pressure monitor2022-11-22
K192633 — GUS831 Compressor Nebulizer2020-05-01
K192609 — Globalcare Blood Pressure Monitor2020-04-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.