FDA 510(k)

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)

N.º K: K191982 · 2020-09-25

SolicitanteShenzhen Kentro Medical Electronics Co., Ltd.

Fecha de decisión2020-09-25

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K191982. 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 Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)?

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K191982.

When did Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) receive FDA 510(k) clearance?

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) received FDA 510(k) clearance on 2020-09-25, under 510(k) number K191982.

Who is the listed applicant for Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)?

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

What is the FDA product code for Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)?

The FDA product code for Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) is NUH.

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Otros registros que enlistan a Shenzhen Kentro Medical Electronics Co., Ltd. como solicitante

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Fuente oficial

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