IRTFDA Class 2 · 21 CFR 890.5740
Pad, Heating, Powered
Device family · Physical Medicine
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
42
Manufacturers
5
Flagged signals
19
Adverse-event reports
3,479
Code matrix
| FDA product code | IRT |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5740 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2014 | 18 | 176.1 | 2,964 |
| Other | 2010 | 39 | 151.8 | 5,696 |
| Other | 2015 | 12 | 117.4 | 1,272 |
| Other | 2011 | 30 | 116.8 | 3,330 |
| Other | 2012 | 28 | 109.0 | 2,890 |
| Other | 2009 | 17 | 66.1 | 1,027 |
| Other | 2010 | 11 | 42.8 | 409 |
| Other | 2014 | 14 | 37.7 | 465 |
| Other | 2008 | 9 | 35.0 | 265 |
| 2014 | 3 | 33.5 | 65 | |
| Other | 2013 | 8 | 31.1 | 204 |
| Other | 2013 | 3 | 29.3 | 56 |
| Other | 2014 | 5 | 19.4 | 70 |
| Other | 2008 | 4 | 15.6 | 41 |
| Other | 2015 | 4 | 10.8 | 26 |
| Other | 2013 | 4 | 10.8 | 26 |
| Injury | 2026 | 10 | 2.6 | 14 |
| Injury | 2023 | 4 | 2.6 | 4 |
| Injury | 2023 | 204 | 2.2 | 204 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 3,479 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| MibeTec GmbH | 2 | 2025 | — |
| Beiersdorf, Inc. | 1 | 1994 | — |
| Maddak, Inc. | 1 | 1984 | — |
| DIGITAL HEAT CORPORATION | 1 | 2015 | — |
| Battle Creek Equipment Co. | 1 | 1985 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
bite away two · mibeTec GmbH510(k) · 2025-09-12
bite away neo · mibeTec GmbH510(k) · 2022-06-23
Bite Away · Riemser Pharma510(k) · 2016-08-26
Heated Eye Pad · Digital Heat Corporation510(k) · 2015-02-09
AVACEN 100 · Avacen, Inc.510(k) · 2014-08-15
FIR HEAT THERAPHY SYSYEMS · Shenzhen Anpan Technology Co., Ltd.510(k) · 2011-11-08
BIO-MAT 2000 · Richway Intl., Inc.510(k) · 2008-02-08
PT-PAC PORTABLE HEATING PAD · Anthony A. Chiurco510(k) · 1997-03-31
LI'S ITCH STOPPER · Hontech Foundation For Medical Technology510(k) · 1996-12-12
HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 · Sunbeam Health Division510(k) · 1996-11-27
HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 · Sunbeam Health Division510(k) · 1996-11-25
PES HOT/COLD COMPRESS · Princeton Electronic Systems, Inc.510(k) · 1996-11-13
FEMININE HEAT WRAP · Conair Corp.510(k) · 1994-10-03
ELASTOPLAST HEAT PLASTER · Beiersdorf, Inc.510(k) · 1994-02-25
ARTHRITIC HEAT WRAP · Conair Corp.510(k) · 1994-02-02
KING SIZE HEAT PAD · Conair Corp.510(k) · 1993-10-12
MOIST HEAT PAD · Conair Corp.510(k) · 1993-10-12
MOSIST HEAT PAD WITH AUTOMATIC OFF · Conair Corp.510(k) · 1993-10-12
THERMODYN · Nemectron Medical, Inc.510(k) · 1993-05-26
PNEUMATHERM · National Pain Institute510(k) · 1993-02-23
SPORTS HEAT WRAP · Conair Corp.510(k) · 1991-12-20
DUNLAP HEAT PAD · Home Healthcare Products, Inc.510(k) · 1991-08-12
SANDBOX I, SANDBOX II, SANDBOX JR. · Sandbox Ent.510(k) · 1991-02-19
INFRASSAGE MASSAGER · Conair Corp.510(k) · 1990-07-25
BCS NO. 1, BODY CARE SYSTEM · M & A Vertrieb, Liske Und Methling GM510(k) · 1988-11-16
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.