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FDA 510(k)

SUNCO Mechanical Wheelchair, model SKW-9003

N.º K: K153328 · 2016-07-20

SolicitanteDanyang Sunco Machinery Co., Ltd.
Fecha de decisión2016-07-20
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

SUNCO Mechanical Wheelchair, model SKW-9003 is the device name listed in this FDA 510(k) record. The listed applicant is Danyang Sunco Machinery Co., Ltd.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K153328. 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 SUNCO Mechanical Wheelchair, model SKW-9003?

SUNCO Mechanical Wheelchair, model SKW-9003 is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Danyang Sunco Machinery Co., Ltd.. The 510(k) number is K153328.

When did SUNCO Mechanical Wheelchair, model SKW-9003 receive FDA 510(k) clearance?

SUNCO Mechanical Wheelchair, model SKW-9003 received FDA 510(k) clearance on 2016-07-20, under 510(k) number K153328.

Who is the listed applicant for SUNCO Mechanical Wheelchair, model SKW-9003?

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

What is the FDA product code for SUNCO Mechanical Wheelchair, model SKW-9003?

The FDA product code for SUNCO Mechanical Wheelchair, model SKW-9003 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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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