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FDA 510(k)

RoughRider Aurora Manual Wheelchair

N.º K: K200715 · 2022-06-24

SolicitanteRoughrider America, LLC
Fecha de decisión2022-06-24
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

RoughRider Aurora Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Roughrider America, LLC. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K200715. 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 RoughRider Aurora Manual Wheelchair?

RoughRider Aurora Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Roughrider America, LLC. The 510(k) number is K200715.

When did RoughRider Aurora Manual Wheelchair receive FDA 510(k) clearance?

RoughRider Aurora Manual Wheelchair received FDA 510(k) clearance on 2022-06-24, under 510(k) number K200715.

Who is the listed applicant for RoughRider Aurora Manual Wheelchair?

The FDA 510(k) record lists Roughrider America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RoughRider Aurora Manual Wheelchair?

The FDA product code for RoughRider Aurora Manual Wheelchair 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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