FDA 510(k)

Merits P335 Powered Wheelchair

Número K: K220529 · 2022-03-18

RequerenteMerits Health Products Co., Ltd.

Data da decisão2022-03-18

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Merits P335 Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K220529. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Merits P335 Powered Wheelchair?

Merits P335 Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K220529.

When did Merits P335 Powered Wheelchair receive FDA 510(k) clearance?

Merits P335 Powered Wheelchair received FDA 510(k) clearance on 2022-03-18, under 510(k) number K220529.

Who is the listed applicant for Merits P335 Powered Wheelchair?

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

What is the FDA product code for Merits P335 Powered Wheelchair?

The FDA product code for Merits P335 Powered Wheelchair is ITI.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: ITI)

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.