Cryo And Thermo Therapy System— 510(k) K253919
Substantially EquivalentXiamen Weiyou Intelligent Technology Co., Ltd.
FDA 510(k) clearance K253919 for Cryo And Thermo Therapy System, Substantially Equivalent on 2026-06-10. Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.. Device class: 2.
Summary
Xiamen Weiyou Intelligent Technology's Cryo And Thermo Therapy System is filed under IRP, powered inflatable tube massagers. The name refers to cryo and thermo therapy, which the code name doesn't mention, and the record doesn't explain the fit.
Class II, 21 CFR 890.5650. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Weiyou filed from Xiamen, China. Review took 184 calendar days (December 8, 2025 to June 10, 2026).
Clearance details
- Applicant
- Xiamen Weiyou Intelligent Technology Co., Ltd.
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiamen, CN
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More clearances from Xiamen Weiyou Intelligent Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.