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FDA 510(k)

Bowhead ERA Wheelchairs

N.º K: K243111 · 2025-01-10

SolicitanteBowhead Design Corp.
Fecha de decisión2025-01-10
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Bowhead ERA Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Bowhead Design Corp.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K243111. 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 Bowhead ERA Wheelchairs?

Bowhead ERA Wheelchairs is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Bowhead Design Corp.. The 510(k) number is K243111.

When did Bowhead ERA Wheelchairs receive FDA 510(k) clearance?

Bowhead ERA Wheelchairs received FDA 510(k) clearance on 2025-01-10, under 510(k) number K243111.

Who is the listed applicant for Bowhead ERA Wheelchairs?

The FDA 510(k) record lists Bowhead Design Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bowhead ERA Wheelchairs?

The FDA product code for Bowhead ERA Wheelchairs is IOR.

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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.

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Fuente oficial

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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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