FDA 510(k)

Pain Therapy Device

Número K: K163611 · 2017-09-19

RequerenteGuangzhou Xinbo Electronic Co., Ltd.

Data da decisão2017-09-19

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pain Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K163611. 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 Pain Therapy Device?

Pain Therapy Device is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K163611.

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

Pain Therapy Device received FDA 510(k) clearance on 2017-09-19, under 510(k) number K163611.

Who is the listed applicant for Pain Therapy Device?

The FDA 510(k) record lists Guangzhou Xinbo Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pain Therapy Device?

The FDA product code for Pain Therapy Device is NUH.

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Outros registros que listam Guangzhou Xinbo Electronic Co., Ltd. como candidato(a)

K230711Pain Therapy Device(Model: P.T.S-X)K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)K231164Conductive carbon film electrode K231167Conductive Silicone Rubber Electrode K202671DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)K212948Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)

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