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FDA 510(k)

Cryo And Thermo Therapy System

K-Number: K253919 · 2026-06-10

Decision Date2026-06-10
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Xiamen Weiyou Intelligent Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.