FDA 510(k)

Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)

N.º K: K231789 · 2024-03-11

SolicitanteGuangzhou Xinbo Electronic Co., Ltd.

Fecha de decisión2024-03-11

Código de productoNGX

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) 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 2024-03-11 under 510(k) number K231789. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)?

Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K231789.

When did Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) receive FDA 510(k) clearance?

Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) received FDA 510(k) clearance on 2024-03-11, under 510(k) number K231789.

Who is the listed applicant for Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)?

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 (Model: P.T.S-VI, P.T.S-VII)?

The FDA product code for Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) is NGX.

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Otros registros que enlistan a Guangzhou Xinbo Electronic Co., Ltd. como solicitante

K230711Pain Therapy Device(Model: P.T.S-X)K231167Conductive Silicone Rubber Electrode K231164Conductive carbon film 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)K202636Metallic Fabric Electrodes

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Fuente oficial

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