IRT
- Product code
- IRT
- Device name
- Pad, Heating, Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5740
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 42
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250047 | 2025-09-12 | mibeTec GmbH | bite away two |
Official FDA classification page: IRT
Classification and pathway per current FDA publications. Data from openFDA (CC0).