IRT — Pad, Heating, Powered Class II
FDA product code IRT covers "Pad, Heating, Powered", a Class II medical device regulated under 21 CFR 890.5740. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IRT
- Device Class
- Class II
- Regulation Number
- 890.5740
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250047 | mibetec | bite away two | September 12, 2025 |
| K220514 | mibetec | bite away neo | June 23, 2022 |
| K160943 | riemser pharma | Bite Away | August 26, 2016 |
| K142228 | digital heat corporation | Heated Eye Pad | February 9, 2015 |
| K133981 | avacen | AVACEN 100 | August 15, 2014 |
| K111273 | shenzhen anpan technology co | FIR HEAT THERAPHY SYSYEMS | November 8, 2011 |
| K072534 | richway intl | BIO-MAT 2000 | February 8, 2008 |
| K963887 | anthony a. chiurco | PT-PAC PORTABLE HEATING PAD | March 31, 1997 |
| K963824 | hontech foundation for medical technology | LI'S ITCH STOPPER | December 12, 1996 |
| K962195 | sunbeam health division | HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 | November 27, 1996 |
| K962252 | sunbeam health division | HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 | November 25, 1996 |
| K962038 | princeton electronic systems | PES HOT/COLD COMPRESS | November 13, 1996 |
| K924970 | conair | FEMININE HEAT WRAP | October 3, 1994 |
| K925630 | beiersdorf | ELASTOPLAST HEAT PLASTER | February 25, 1994 |
| K925820 | conair | ARTHRITIC HEAT WRAP | February 2, 1994 |
| K924885 | conair | KING SIZE HEAT PAD | October 12, 1993 |
| K924800 | conair | MOSIST HEAT PAD WITH AUTOMATIC OFF | October 12, 1993 |
| K924799 | conair | MOIST HEAT PAD | October 12, 1993 |
| K923396 | nemectron medical | THERMODYN | May 26, 1993 |
| K922089 | national pain institute | PNEUMATHERM | February 23, 1993 |