FDA 510(k)

TENS and EMS Stimulation (OTC)

Número K: K230163 · 2023-03-20

RequerenteChangsha Yuwen Medical Equipment Co., Ltd.

Data da decisão2023-03-20

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TENS and EMS Stimulation (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K230163. 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 TENS and EMS Stimulation (OTC)?

TENS and EMS Stimulation (OTC) is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. The 510(k) number is K230163.

When did TENS and EMS Stimulation (OTC) receive FDA 510(k) clearance?

TENS and EMS Stimulation (OTC) received FDA 510(k) clearance on 2023-03-20, under 510(k) number K230163.

Who is the listed applicant for TENS and EMS Stimulation (OTC)?

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

What is the FDA product code for TENS and EMS Stimulation (OTC)?

The FDA product code for TENS and EMS Stimulation (OTC) is NUH.

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Outros registros que listam Changsha Yuwen Medical Equipment Co., Ltd. como candidato(a)

K230164TENS and EMS Stimulation (OTC)K230174TENS and EMS Stimulation (OTC)K212184TENS and EMS Stimulation (OTC)

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

Fonte oficial

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