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FDA 510(k)

Merits Model R106/R136 Rehab Wheelchair

N.º K: K170517 · 2017-11-16

SolicitanteMerits Healthcare Industries (Suzhou) Co., Ltd.
Fecha de decisión2017-11-16
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Merits Model R106/R136 Rehab Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Merits Healthcare Industries (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K170517. 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 Merits Model R106/R136 Rehab Wheelchair?

Merits Model R106/R136 Rehab Wheelchair is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Merits Healthcare Industries (Suzhou) Co., Ltd.. The 510(k) number is K170517.

When did Merits Model R106/R136 Rehab Wheelchair receive FDA 510(k) clearance?

Merits Model R106/R136 Rehab Wheelchair received FDA 510(k) clearance on 2017-11-16, under 510(k) number K170517.

Who is the listed applicant for Merits Model R106/R136 Rehab Wheelchair?

The FDA 510(k) record lists Merits Healthcare Industries (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merits Model R106/R136 Rehab Wheelchair?

The FDA product code for Merits Model R106/R136 Rehab 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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