K253150
- 510(k) number
- K253150
- Device name
- Cryon-X Cold Compression
- Applicant
- Jkh Health Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2025-10-24
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253150.pdf
Official FDA record: K253150
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.