FDA 510(k)

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4

Numéro K : K251856 · 2025-11-21

DemandeurEveryway Medical Instruments Co.,Ltd

Date de décision2025-11-21

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K251856. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K251856.

When did Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 receive FDA 510(k) clearance?

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 received FDA 510(k) clearance on 2025-11-21, under 510(k) number K251856.

Who is the listed applicant for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

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

What is the FDA product code for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

The FDA product code for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is NUH.

Essais cliniques associés

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Autres dossiers indiquant Everyway Medical Instruments Co.,Ltd en tant que demandeur

K222488Everyway Analog OTC TENS K213116Everyway Incontinence Stimulation System K202849Everyway Analog OTC TENS, model N103A/N302 K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 K201335Li-Battery powered OTC TENS/EMS Combination Stimulator

Voir tous les 13 dispositifs →

Dispositifs connexes (Code : NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd 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.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.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 Limited

Source officielle

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