K260903
- 510(k) number
- K260903
- Device name
- Hot Pink Pad Warming System
- Applicant
- Xodus Medical, Inc. PA · US
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2026-04-16
- Date received
- 2026-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260903.pdf
Official FDA record: K260903
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.