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FDA 510(k)

e-Throne Folding Wheelchair, Model: ET-12F22

N.º K: K191105 · 2022-01-21

SolicitanteGolden Motor Technology Co., Ltd.
Fecha de decisión2022-01-21
Código de productoITI
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

e-Throne Folding Wheelchair, Model: ET-12F22 is the device name listed in this FDA 510(k) record. The listed applicant is Golden Motor Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K191105. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the e-Throne Folding Wheelchair, Model: ET-12F22?

e-Throne Folding Wheelchair, Model: ET-12F22 is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Golden Motor Technology Co., Ltd.. The 510(k) number is K191105.

When did e-Throne Folding Wheelchair, Model: ET-12F22 receive FDA 510(k) clearance?

e-Throne Folding Wheelchair, Model: ET-12F22 received FDA 510(k) clearance on 2022-01-21, under 510(k) number K191105.

Who is the listed applicant for e-Throne Folding Wheelchair, Model: ET-12F22?

The FDA 510(k) record lists Golden Motor Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e-Throne Folding Wheelchair, Model: ET-12F22?

The FDA product code for e-Throne Folding Wheelchair, Model: ET-12F22 is ITI.

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Dispositivos relacionados (Código: ITI)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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