FDA 510(k)

Everyway Wireless TENS & EMS Unit

Número K: K181707 · 2018-09-26

RequerenteEveryway Medical Instruments Co.,Ltd

Data da decisão2018-09-26

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Everyway Wireless TENS & EMS Unit 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 2018-09-26 under 510(k) number K181707. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Everyway Wireless TENS & EMS Unit?

Everyway Wireless TENS & EMS Unit is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K181707.

When did Everyway Wireless TENS & EMS Unit receive FDA 510(k) clearance?

Everyway Wireless TENS & EMS Unit received FDA 510(k) clearance on 2018-09-26, under 510(k) number K181707.

Who is the listed applicant for Everyway Wireless TENS & EMS Unit?

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 Everyway Wireless TENS & EMS Unit?

The FDA product code for Everyway Wireless TENS & EMS Unit is NUH.

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Outros registros que listam Everyway Medical Instruments Co.,Ltd como candidato(a)

K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 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

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Dispositivos Relacionados (Código: 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

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