K250047
- 510(k) number
- K250047
- Device name
- bite away two
- Applicant
- mibeTec GmbH DE
- Product code
- IRT — Pad, Heating, Powered
- Decision date
- 2025-09-12
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250047.pdf
Official FDA record: K250047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.