bite away two
by mibeTec GmbH
510(k) K250047
bite away two is a Class II device made by mibeTec GmbH, cleared under FDA 510(k) K250047 on 12 Sep 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250047 | Date12 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K250047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IRT
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5740
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IRT (Pad, Heating, Powered).
- ARTHRITIC HEAT WRAP by CONAIR LLC.
- THERMODYN by Nemectron Medical, Inc.
- HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 by Sunbeam Health Division
- MY MASK-E/M500N by ESPANSIONE MARKETING SPA
- PASSIVE HEAT PADS by Biotone International, Inc.
- MOIST HEAT PAD by CONAIR LLC.
- PT-PAC PORTABLE HEATING PAD by Anthony A. Chiurco
- FIR HEAT THERAPHY SYSYEMS by Shenzhen Anpan Technology Co., Ltd.
- THERATHERM by Electro Therapeutic Devices, Inc.
- Heated Eye Pad by DIGITAL HEAT CORPORATION