FDA 510(k)

TENS and EMS Stimulation (OTC)

N.º K: K230164 · 2023-04-10

SolicitanteChangsha Yuwen Medical Equipment Co., Ltd.

Fecha de decisión2023-04-10

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del 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 2023-04-10 under 510(k) number K230164. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TENS and EMS Stimulation (OTC)?

TENS and EMS Stimulation (OTC) is a medical device that received FDA 510(k) clearance on 2023-04-10. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. The 510(k) number is K230164.

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

TENS and EMS Stimulation (OTC) received FDA 510(k) clearance on 2023-04-10, under 510(k) number K230164.

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Changsha Yuwen Medical Equipment Co., Ltd. como solicitante

K230174TENS and EMS Stimulation (OTC)K230163TENS 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

Fuente oficial

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