FDA 510(k)

Mini TENS Therapy Device

N.º K: K182871 · 2019-08-01

SolicitanteShenzhen Jumper Medical Equipment Co., Ltd.

Fecha de decisión2019-08-01

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Mini TENS Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K182871. 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 Mini TENS Therapy Device?

Mini TENS Therapy Device is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. The 510(k) number is K182871.

When did Mini TENS Therapy Device receive FDA 510(k) clearance?

Mini TENS Therapy Device received FDA 510(k) clearance on 2019-08-01, under 510(k) number K182871.

Who is the listed applicant for Mini TENS Therapy Device?

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

What is the FDA product code for Mini TENS Therapy Device?

The FDA product code for Mini TENS Therapy Device is NUH.

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Otros registros que enlistan a Shenzhen Jumper Medical Equipment Co., Ltd. como solicitante

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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

Fuente oficial

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