Product code IRT
- Device name
- Pad, Heating, Powered
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5740
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250047 | bite away two | mibeTec GmbH | 2025-09-12 |
| K220514 | bite away neo | mibeTec GmbH | 2022-06-23 |
| K160943 | Bite Away | Riemser Pharma | 2016-08-26 |
| K142228 | Heated Eye Pad | Digital Heat Corporation | 2015-02-09 |
| K133981 | AVACEN 100 | Avacen, Inc. | 2014-08-15 |
| K111273 | FIR HEAT THERAPHY SYSYEMS | Shenzhen Anpan Technology Co., Ltd. | 2011-11-08 |
| K072534 | BIO-MAT 2000 | Richway Intl., Inc. | 2008-02-08 |
| K963887 | PT-PAC PORTABLE HEATING PAD | Anthony A. Chiurco | 1997-03-31 |
| K963824 | LI'S ITCH STOPPER | Hontech Foundation For Medical Technology | 1996-12-12 |
| K962195 | HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 | Sunbeam Health Division | 1996-11-27 |
| K962252 | HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 | Sunbeam Health Division | 1996-11-25 |
| K962038 | PES HOT/COLD COMPRESS | Princeton Electronic Systems, Inc. | 1996-11-13 |
| K924970 | FEMININE HEAT WRAP | Conair Corp. | 1994-10-03 |
| K925630 | ELASTOPLAST HEAT PLASTER | Beiersdorf, Inc. | 1994-02-25 |
| K925820 | ARTHRITIC HEAT WRAP | Conair Corp. | 1994-02-02 |
| K924885 | KING SIZE HEAT PAD | Conair Corp. | 1993-10-12 |
| K924800 | MOSIST HEAT PAD WITH AUTOMATIC OFF | Conair Corp. | 1993-10-12 |
| K924799 | MOIST HEAT PAD | Conair Corp. | 1993-10-12 |
| K923396 | THERMODYN | Nemectron Medical, Inc. | 1993-05-26 |
| K922089 | PNEUMATHERM | National Pain Institute | 1993-02-23 |
| K915241 | SPORTS HEAT WRAP | Conair Corp. | 1991-12-20 |
| K911195 | DUNLAP HEAT PAD | Home Healthcare Products, Inc. | 1991-08-12 |
| K903321 | SANDBOX I, SANDBOX II, SANDBOX JR. | Sandbox Ent. | 1991-02-19 |
| K902895 | INFRASSAGE MASSAGER | Conair Corp. | 1990-07-25 |
| K881800 | BCS NO. 1, BODY CARE SYSTEM | M & A Vertrieb, Liske Und Methling GM | 1988-11-16 |
| K882151 | PORT-O-HEAT, MODEL 0100 | Arthotronics, Inc. | 1988-11-04 |
| K881862 | THERMO-BODY-WRAP SYSTEM | Thermo Body Wrap Systems, Inc. | 1988-10-13 |
| K873576 | HUCHEL BODYLINER | Hans-Juergen Huchel | 1988-01-19 |
| K873254 | THERMOWRAP, A/K/A/, THERMAL WRAP | Family Sun Tanning | 1987-12-11 |
| K862106 | FORMOSTAR | Lmv, Liske & Methling, GmbH | 1986-08-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09413000135374 | Flowpresso Compression Device | MEDELLA HEALTH LIMITED | 2025-10-16 |
| B311PETNHTPR0 | PURE ENRICHMENT | BEAR DOWN CONSULTING | 2023-12-15 |
| 00011822820240 | Rite Aid | RITE AID CORPORATION | 2022-10-20 |
| 00011822820226 | Rite Aid | RITE AID CORPORATION | 2022-05-31 |
| 16971912180030 | Walgreens heating pad | NINGBO BELLA VIE CO., LTD | 2021-05-11 |
| 16971912180016 | RENPHO heating pad | NINGBO BELLA VIE CO., LTD | 2021-03-31 |
| 16971912180023 | Walgreens heating pad | NINGBO BELLA VIE CO., LTD | 2021-03-31 |
| 10038056000559 | CARA | CARA, INCORPORATED | 2019-08-30 |
| 10038056000566 | CARA | CARA, INCORPORATED | 2019-08-30 |
| 10038056000740 | Cara | CARA, INCORPORATED | 2018-04-23 |
| B556MG33000 | Migun | MIGUN LIFE CO., LTD | 2017-05-01 |
| B556MG36000 | Migun | MIGUN LIFE CO., LTD | 2017-05-01 |
| B556MG31000 | Migun | MIGUN LIFE CO., LTD | 2017-05-01 |
| B556ED3010 | Migun | MIGUN LIFE CO., LTD | 2017-05-01 |
| 00027045743990 | Sunbeam | Jarden Consumer Solutions | 2016-11-29 |
| 00027045730990 | Sunbeam | Jarden Consumer Solutions | 2016-11-29 |
| 00027045712736 | Sunbeam | Jarden Consumer Solutions | 2016-11-29 |
| 00027045646703 | Sunbeam | Jarden Consumer Solutions | 2016-11-23 |
| 00027045646697 | Sunbeam | Jarden Consumer Solutions | 2016-11-21 |
| 00027045726344 | Sunbeam | Jarden Consumer Solutions | 2016-09-23 |
| 00027045640732 | Sunbeam | Jarden Consumer Solutions | 2016-09-23 |
| 00027045640756 | Sunbeam | Jarden Consumer Solutions | 2016-09-23 |
| 00027045697408 | Sunbeam | Jarden Consumer Solutions | 2016-09-23 |
| 00027045712712 | Sunbeam | Jarden Consumer Solutions | 2016-09-23 |
| 00027045744003 | Sunbeam | Jarden Consumer Solutions | 2016-09-22 |
| B344ED3010 | Migun | MIGUN LIFE INC | 2016-09-22 |
| B344MG31000 | Migun | MIGUN LIFE INC | 2016-09-22 |
| B344MG33000 | Migun | MIGUN LIFE INC | 2016-09-22 |
| B344MG36000 | Migun | MIGUN LIFE INC | 2016-09-22 |
| M368450711 | Grafco | GF HEALTH PRODUCTS, INC. | 2016-08-31 |