IRT
42 FDA 510(k) clearances · Product code
154 daysmedian time to decision
383 days90th percentile
42clearances measured
FDA profile
- Official device name
- Pad, Heating, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5740
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 2021: 97 · 2022: 134 · 2023: 321 · 2024: 77 · 2025: 71 · 2026: 104
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| bite away two (K250047) | mibeTec GmbH | 2025-09-12 |
| bite away neo (K220514) | mibeTec GmbH | 2022-06-23 |
| Bite Away (K160943) | Riemser Pharma | 2016-08-26 |
| Heated Eye Pad (K142228) | Digital Heat Corporation | 2015-02-09 |
| AVACEN 100 (K133981) | Avacen, Inc. | 2014-08-15 |
| FIR HEAT THERAPHY SYSYEMS (K111273) | Shenzhen Anpan Technology Co., Ltd. | 2011-11-08 |
| BIO-MAT 2000 (K072534) | Richway Intl., Inc. | 2008-02-08 |
| PT-PAC PORTABLE HEATING PAD (K963887) | Anthony A. Chiurco | 1997-03-31 |
| LI'S ITCH STOPPER (K963824) | Hontech Foundation For Medical Technology | 1996-12-12 |
| HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 (K962195) | Sunbeam Health Division | 1996-11-27 |
| HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (K962252) | Sunbeam Health Division | 1996-11-25 |
| PES HOT/COLD COMPRESS (K962038) | Princeton Electronic Systems, Inc. | 1996-11-13 |
| FEMININE HEAT WRAP (K924970) | Conair Corp. | 1994-10-03 |
| ELASTOPLAST HEAT PLASTER (K925630) | Beiersdorf, Inc. | 1994-02-25 |
| ARTHRITIC HEAT WRAP (K925820) | Conair Corp. | 1994-02-02 |
| MOSIST HEAT PAD WITH AUTOMATIC OFF (K924800) | Conair Corp. | 1993-10-12 |
| MOIST HEAT PAD (K924799) | Conair Corp. | 1993-10-12 |
| KING SIZE HEAT PAD (K924885) | Conair Corp. | 1993-10-12 |
| THERMODYN (K923396) | Nemectron Medical, Inc. | 1993-05-26 |
| PNEUMATHERM (K922089) | National Pain Institute | 1993-02-23 |
| SPORTS HEAT WRAP (K915241) | Conair Corp. | 1991-12-20 |
| DUNLAP HEAT PAD (K911195) | Home Healthcare Products, Inc. | 1991-08-12 |
| SANDBOX I, SANDBOX II, SANDBOX JR. (K903321) | Sandbox Ent. | 1991-02-19 |
| INFRASSAGE MASSAGER (K902895) | Conair Corp. | 1990-07-25 |
| BCS NO. 1, BODY CARE SYSTEM (K881800) | M & A Vertrieb, Liske Und Methling GM | 1988-11-16 |
| PORT-O-HEAT, MODEL 0100 (K882151) | Arthotronics, Inc. | 1988-11-04 |
| THERMO-BODY-WRAP SYSTEM (K881862) | Thermo Body Wrap Systems, Inc. | 1988-10-13 |
| HUCHEL BODYLINER (K873576) | Hans-Juergen Huchel | 1988-01-19 |
| THERMOWRAP, A/K/A/, THERMAL WRAP (K873254) | Family Sun Tanning | 1987-12-11 |
| FORMOSTAR (K862106) | Lmv, Liske & Methling, GmbH | 1986-08-21 |
| SOLEX THERAPEUTIC PAD (K861383) | Intl. Diathermics Research, Inc. | 1986-04-18 |
| THERMO TRIM (K852637) | Suntec Health & Fitness Group, Inc. | 1985-11-20 |
| MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK (K852604) | Clairol, Inc. | 1985-08-12 |
| THERMOPHORE ELECTRIC FOMENTATION UNIT (K851237) | Battle Creek Equipment Co. | 1985-07-29 |
| HYDRO-THERO PAD (K841697) | Maddak, Inc. | 1984-05-09 |
| HP-20, 30, 40, 50 & 60 (K841100) | Associated Mills, Inc. | 1984-03-23 |
| MICROPAD (K823301) | Fia Man Co. | 1982-12-03 |
| PASSIVE HEAT PADS (K821692) | Biotone International, Inc. | 1982-07-13 |
| DELUXE HEAT WRAP/COLD WRAP (K801081) | The Gillette Company | 1980-05-14 |
| THERMAL CONDITIONING SYSTEM (K791154) | Acurex Aerotherm | 1979-10-09 |
| GILLETTE HEAT WRAP (K790374) | The Gillette Company | 1979-04-10 |
| THERATHERM (K770686) | Electro Therapeutic Devices, Inc. | 1977-07-14 |
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Every clearance here is in the API, with alerts when new ones post.