FDA 510(k)

Cryo And Thermo Therapy System

N.º K: K253919 · 2026-06-10

SolicitanteXiamen Weiyou Intelligent Technology Co., Ltd.

Fecha de decisión2026-06-10

Código de productoIRP

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cryo And Thermo Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Weiyou Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K253919. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cryo And Thermo Therapy System?

Cryo And Thermo Therapy System is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Xiamen Weiyou Intelligent Technology Co., Ltd.. The 510(k) number is K253919.

When did Cryo And Thermo Therapy System receive FDA 510(k) clearance?

Cryo And Thermo Therapy System received FDA 510(k) clearance on 2026-06-10, under 510(k) number K253919.

Who is the listed applicant for Cryo And Thermo Therapy System?

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

What is the FDA product code for Cryo And Thermo Therapy System?

The FDA product code for Cryo And Thermo Therapy System is IRP.

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Otros registros que enlistan a Xiamen Weiyou Intelligent Technology Co., Ltd. como solicitante

K253064Sistema de Terapia de Presión de Aire (VU-IPC8M); Sistema de Terapia de Presión de Aire (VU-IPC6M); Sistema de Terapia de Presión de Aire (VU-IPC4X)K243791Sistema de Terapia de Presión de Aire K243320Sistema de Terapia de Presión de Aire (VU-IPC04B)K233238Sistema de Terapia de Presión de Aire (Modelo: VU-IPC4M)K201935Sistema de Terapia de Presión de Aire K210967Sistema de Terapia de Presión de Aire: VU-IPC06

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