K253919
- 510(k) number
- K253919
- Device name
- Cryo And Thermo Therapy System
- Applicant
- Xiamen Weiyou Intelligent Technology Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2026-06-10
- Date received
- 2025-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253919.pdf
Official FDA record: K253919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.