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FDA 510(k)

SUNTEC Mechanical Wheelchair, model ST-WL-1000

N.º K: K152878 · 2016-02-03

SolicitanteDanyang Suntec Auto Parts Co., Ltd.
Fecha de decisión2016-02-03
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

SUNTEC Mechanical Wheelchair, model ST-WL-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Danyang Suntec Auto Parts Co., Ltd.. It received FDA 510(k) clearance on 2016-02-03 under 510(k) number K152878. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SUNTEC Mechanical Wheelchair, model ST-WL-1000?

SUNTEC Mechanical Wheelchair, model ST-WL-1000 is a medical device that received FDA 510(k) clearance on 2016-02-03. The listed applicant is Danyang Suntec Auto Parts Co., Ltd.. The 510(k) number is K152878.

When did SUNTEC Mechanical Wheelchair, model ST-WL-1000 receive FDA 510(k) clearance?

SUNTEC Mechanical Wheelchair, model ST-WL-1000 received FDA 510(k) clearance on 2016-02-03, under 510(k) number K152878.

Who is the listed applicant for SUNTEC Mechanical Wheelchair, model ST-WL-1000?

The FDA 510(k) record lists Danyang Suntec Auto Parts Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNTEC Mechanical Wheelchair, model ST-WL-1000?

The FDA product code for SUNTEC Mechanical Wheelchair, model ST-WL-1000 is IOR.

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Dispositivos relacionados (Código: IOR)

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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