FDA 510(k)

Wireless Pain Relieve Device

Número K: K180331 · 2018-06-22

RequerenteShenzhen Dongdixin Technology Co., Ltd.

Data da decisão2018-06-22

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Shenzhen Dongdixin Technology Co., Ltd. como candidato(a)

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)

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Fonte oficial

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