FDA 510(k)

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

N.º K: K220998 · 2022-08-24

SolicitanteShenzhen Kentro Medical Electronics Co., Ltd.

Fecha de decisión2022-08-24

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 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 2022-08-24 under 510(k) number K220998. 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 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K220998.

When did Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 received FDA 510(k) clearance on 2022-08-24, under 510(k) number K220998.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

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 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

The FDA product code for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is NUH.

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

K242332Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)K232517Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)K222870Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 K200177Low-frequency Multi-function physiotherapy instrument K200237Transcutaneous Electronic Nerve Stimulator K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)

Ver todos los 10 dispositivos →

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Fuente oficial

Ver en la base de datos de la FDA →

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