Submission Details
| 510(k) Number | K250047 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2025 |
| Decision Date | September 12, 2025 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
bite away two
Sep 2025
Decision
245d
Days
Class 2
Risk
About This 510(k) Submission
K250047 is an FDA 510(k) clearance for the bite away two, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by mibeTec GmbH (Brehna, DE). The FDA issued a Cleared decision on September 12, 2025, 245 days after receiving the submission on January 10, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.
Device Classification
| Product Code | IRT — Pad, Heating, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5740 |
Manufacturer
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