Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Powered Wheelchair (PL001-9001)

N.º K: K252829 · 2025-11-12

SolicitanteSuzhou KD Intelligent Device Co., Ltd.
Fecha de decisión2025-11-12
Código de productoITI
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Powered Wheelchair (PL001-9001) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou KD Intelligent Device Co., Ltd.. It received FDA 510(k) clearance on 2025-11-12 under 510(k) number K252829. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Powered Wheelchair (PL001-9001)?

Powered Wheelchair (PL001-9001) is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Suzhou KD Intelligent Device Co., Ltd.. The 510(k) number is K252829.

When did Powered Wheelchair (PL001-9001) receive FDA 510(k) clearance?

Powered Wheelchair (PL001-9001) received FDA 510(k) clearance on 2025-11-12, under 510(k) number K252829.

Who is the listed applicant for Powered Wheelchair (PL001-9001)?

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

What is the FDA product code for Powered Wheelchair (PL001-9001)?

The FDA product code for Powered Wheelchair (PL001-9001) is ITI.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: ITI)

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.

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.

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.

↑