FDA Product Code
FDA Product Code IRT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5740
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250047 | bite away two | mibeTec GmbH | 2025-09-12 | Traditional | PDF ↗ |
| K220514 | bite away neo | mibeTec GmbH | 2022-06-23 | Traditional | PDF ↗ |
| K160943 | Bite Away | Riemser Pharma | 2016-08-26 | Traditional | PDF ↗ |
| K142228 | Heated Eye Pad | Digital Heat Corporation | 2015-02-09 | Traditional | PDF ↗ |
| K133981 | AVACEN 100 | Avacen, Inc. | 2014-08-15 | Abbreviated | PDF ↗ |
| K111273 | FIR HEAT THERAPHY SYSYEMS | Shenzhen Anpan Technology Co., Ltd. | 2011-11-08 | Traditional | PDF ↗ |
| K072534 | BIO-MAT 2000 | Richway Intl., Inc. | 2008-02-08 | Traditional | PDF ↗ |
| K963887 | PT-PAC PORTABLE HEATING PAD | Anthony A. Chiurco | 1997-03-31 | Traditional | PDF ↗ |
| K963824 | LI'S ITCH STOPPER | Hontech Foundation For Medical Technology | 1996-12-12 | Traditional | PDF ↗ |
| K962195 | HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 | Sunbeam Health Division | 1996-11-27 | Traditional | PDF ↗ |
| K962252 | HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 | Sunbeam Health Division | 1996-11-25 | Traditional | PDF ↗ |
| K962038 | PES HOT/COLD COMPRESS | Princeton Electronic Systems, Inc. | 1996-11-13 | Traditional | PDF ↗ |
| K924970 | FEMININE HEAT WRAP | Conair Corp. | 1994-10-03 | Traditional | PDF ↗ |
| K925630 | ELASTOPLAST HEAT PLASTER | Beiersdorf, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K925820 | ARTHRITIC HEAT WRAP | Conair Corp. | 1994-02-02 | Traditional | PDF ↗ |
| K924800 | MOSIST HEAT PAD WITH AUTOMATIC OFF | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924885 | KING SIZE HEAT PAD | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924799 | MOIST HEAT PAD | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K923396 | THERMODYN | Nemectron Medical, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K922089 | PNEUMATHERM | National Pain Institute | 1993-02-23 | Traditional | PDF ↗ |
| K915241 | SPORTS HEAT WRAP | Conair Corp. | 1991-12-20 | Traditional | PDF ↗ |
| K911195 | DUNLAP HEAT PAD | Home Healthcare Products, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K903321 | SANDBOX I, SANDBOX II, SANDBOX JR. | Sandbox Ent. | 1991-02-19 | Traditional | PDF ↗ |
| K902895 | INFRASSAGE MASSAGER | Conair Corp. | 1990-07-25 | Traditional | PDF ↗ |
| K881800 | BCS NO. 1, BODY CARE SYSTEM | M & A Vertrieb, Liske Und Methling GM | 1988-11-16 | Traditional | PDF ↗ |
| K882151 | PORT-O-HEAT, MODEL 0100 | Arthotronics, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K881862 | THERMO-BODY-WRAP SYSTEM | Thermo Body Wrap Systems, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K873576 | HUCHEL BODYLINER | Hans-Juergen Huchel | 1988-01-19 | Traditional | PDF ↗ |
| K873254 | THERMOWRAP, A/K/A/, THERMAL WRAP | Family Sun Tanning | 1987-12-11 | Traditional | PDF ↗ |
| K862106 | FORMOSTAR | Lmv, Liske & Methling, GmbH | 1986-08-21 | Traditional | PDF ↗ |
| K861383 | SOLEX THERAPEUTIC PAD | Intl. Diathermics Research, Inc. | 1986-04-18 | Traditional | PDF ↗ |
| K852637 | THERMO TRIM | Suntec Health & Fitness Group, Inc. | 1985-11-20 | Traditional | PDF ↗ |
| K852604 | MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK | Clairol, Inc. | 1985-08-12 | Traditional | PDF ↗ |
| K851237 | THERMOPHORE ELECTRIC FOMENTATION UNIT | Battle Creek Equipment Co. | 1985-07-29 | Traditional | PDF ↗ |
| K841697 | HYDRO-THERO PAD | Maddak, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K841100 | HP-20, 30, 40, 50 & 60 | Associated Mills, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K823301 | MICROPAD | Fia Man Co. | 1982-12-03 | Traditional | PDF ↗ |
| K821692 | PASSIVE HEAT PADS | Biotone International, Inc. | 1982-07-13 | Traditional | PDF ↗ |
| K801081 | DELUXE HEAT WRAP/COLD WRAP | The Gillette Company | 1980-05-14 | Traditional | PDF ↗ |
| K791154 | THERMAL CONDITIONING SYSTEM | Acurex Aerotherm | 1979-10-09 | Traditional | PDF ↗ |
| K790374 | GILLETTE HEAT WRAP | The Gillette Company | 1979-04-10 | Traditional | PDF ↗ |
| K770686 | THERATHERM | Electro Therapeutic Devices, Inc. | 1977-07-14 | Traditional | PDF ↗ |
Product code IRT · Class II · Physical Medicine. Data: openFDA.