FDA 510(k)

TENS and EMS Stimulation (OTC)

N.º K: K212184 · 2022-04-01

SolicitanteChangsha Yuwen Medical Equipment Co., Ltd.

Fecha de decisión2022-04-01

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 2022-04-01 under 510(k) number K212184. 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 2022-04-01. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. The 510(k) number is K212184.

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

TENS and EMS Stimulation (OTC) received FDA 510(k) clearance on 2022-04-01, under 510(k) number K212184.

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

K230164TENS and EMS Stimulation (OTC)K230174TENS and EMS Stimulation (OTC)K230163TENS 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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.