K220514 is an FDA 510(k) clearance for the bite away neo. This device is classified as a Pad, Heating, Powered (Class II - Special Controls, product code IRT).
Submitted by mibeTec GmbH (Brehna, DE). The FDA issued a Cleared decision on June 23, 2022, 121 days after receiving the submission on February 22, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5740.
| 510(k) Number | K220514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2022 |
| Decision Date | June 23, 2022 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRT - Pad, Heating, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5740 |