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FDA 510(k)

Pression Wave PRO External Counter-Pulsation System

N.º K: K250756 · 2025-12-22

SolicitantePression, Inc.
Fecha de decisión2025-12-22
Código de productoDRN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Pression Wave PRO External Counter-Pulsation System is the device name listed in this FDA 510(k) record. The listed applicant is Pression, Inc.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) number K250756. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pression Wave PRO External Counter-Pulsation System?

Pression Wave PRO External Counter-Pulsation System is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Pression, Inc.. The 510(k) number is K250756.

When did Pression Wave PRO External Counter-Pulsation System receive FDA 510(k) clearance?

Pression Wave PRO External Counter-Pulsation System received FDA 510(k) clearance on 2025-12-22, under 510(k) number K250756.

Who is the listed applicant for Pression Wave PRO External Counter-Pulsation System?

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

What is the FDA product code for Pression Wave PRO External Counter-Pulsation System?

The FDA product code for Pression Wave PRO External Counter-Pulsation System is DRN.

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Dispositivos relacionados (Código: DRN)

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.

K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.K191955Enhanced External Counter Pulsation Device Plus Omay-AOmay(Guangzhou)Med Technologies Co., Ltd.K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd.K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, 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.

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