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FDA 510(k)

Merlexi Craft Bariatric series of manual wheelchairs

Número K: K240120 · 2024-07-05

RequerenteTurbo Wheelchair Co., Inc.
Data da decisão2024-07-05
Código do produtoIOR
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

Merlexi Craft Bariatric series of manual wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Turbo Wheelchair Co., Inc.. It received FDA 510(k) clearance on 2024-07-05 under 510(k) number K240120. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Merlexi Craft Bariatric series of manual wheelchairs?

Merlexi Craft Bariatric series of manual wheelchairs is a medical device that received FDA 510(k) clearance on 2024-07-05. The listed applicant is Turbo Wheelchair Co., Inc.. The 510(k) number is K240120.

When did Merlexi Craft Bariatric series of manual wheelchairs receive FDA 510(k) clearance?

Merlexi Craft Bariatric series of manual wheelchairs received FDA 510(k) clearance on 2024-07-05, under 510(k) number K240120.

Who is the listed applicant for Merlexi Craft Bariatric series of manual wheelchairs?

The FDA 510(k) record lists Turbo Wheelchair Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merlexi Craft Bariatric series of manual wheelchairs?

The FDA product code for Merlexi Craft Bariatric series of manual wheelchairs is IOR.

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Dispositivos Relacionados (Código: IOR)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

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