FDA 510(k)

Wireless Pain Relieve Device

N.º K: K180331 · 2018-06-22

SolicitanteShenzhen Dongdixin Technology Co., Ltd.

Fecha de decisión2018-06-22

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wireless Pain Relieve Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180331. 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 Wireless Pain Relieve Device?

Wireless Pain Relieve Device is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K180331.

When did Wireless Pain Relieve Device receive FDA 510(k) clearance?

Wireless Pain Relieve Device received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180331.

Who is the listed applicant for Wireless Pain Relieve Device?

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

What is the FDA product code for Wireless Pain Relieve Device?

The FDA product code for Wireless Pain Relieve Device is NUH.

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Otros registros que enlistan a Shenzhen Dongdixin Technology Co., Ltd. como solicitante

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)K240358ShockPhysio Mobile (model SW3200 Basic)K213043Levator Elite (Model LE9011)K210364Migraine Tens Digital Pain Reliever K171430Incontinence Treatment Device, Model LT2061 K173462Wireless Pain Relieve Device Model: LT5018C

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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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