FDA 510(k)

Aura Wave

N.º K: K250896 · 2025-12-02

Fecha de decisión2025-12-02

Código de productoSGT

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aura Wave is the device name listed in this FDA 510(k) record. The listed applicant is Aura Wellness, LLC. It received FDA 510(k) clearance on 2025-12-02 under 510(k) number K250896. The device is classified under product code SGT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aura Wave?

Aura Wave is a medical device that received FDA 510(k) clearance on 2025-12-02. The listed applicant is Aura Wellness, LLC. The 510(k) number is K250896.

When did Aura Wave receive FDA 510(k) clearance?

Aura Wave received FDA 510(k) clearance on 2025-12-02, under 510(k) number K250896.

Who is the listed applicant for Aura Wave?

The FDA 510(k) record lists Aura Wellness, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aura Wave?

The FDA product code for Aura Wave is SGT.

Otros registros que enlistan a Aura Wellness, LLC como solicitante

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.

K262788Nova HD+K220938Nova HD+

Dispositivos relacionados (Código: SGT)

K262788Nova HD+Aura Wellness, LLC

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.