Pad, Heating, Powered
FDA product code IRT · Class II (moderate risk) · 21 CFR 890.5740 · Physical Medicine
42510(k) clearances
0PMA approvals
24recalls
Manufacturers
- Conair Corp. 7
- The Gillette Company 2
- Sunbeam Health Division 2
- mibeTec GmbH 2
- Family Sun Tanning 1
- Electro Therapeutic Devices, Inc. 1
- Acurex Aerotherm 1
- Sandbox Ent. 1
- Biotone International, Inc. 1
- M & A Vertrieb, Liske Und Methling GM 1
- Arthotronics, Inc. 1
- Thermo Body Wrap Systems, Inc. 1
- Hans-Juergen Huchel 1
- Fia Man Co. 1
- Lmv, Liske & Methling, GmbH 1
- Intl. Diathermics Research, Inc. 1
- Suntec Health & Fitness Group, Inc. 1
- Clairol, Inc. 1
- Battle Creek Equipment Co. 1
- Maddak, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250047 | bite away twoIRT · Traditional | mibeTec GmbH | 09/12/2025SE |
| K220514 | bite away neoIRT · Traditional | mibeTec GmbH | 06/23/2022SE |
| K160943 | Bite AwayIRT · Traditional | Riemser Pharma | 08/26/2016SE |
| K142228 | Heated Eye PadIRT · Traditional | Digital Heat Corporation | 02/09/2015SE |
| K133981 | Avacen 100IRT · Abbreviated | Avacen, Inc. | 08/15/2014SE |
| K111273 | Fir Heat Theraphy SysyemsIRT · Traditional | Shenzhen Anpan Technology Co., Ltd. | 11/08/2011SE |
| K072534 | Bio-Mat 2000IRT · Traditional | Richway Intl., Inc. | 02/08/2008SE |
| K963887 | Pt-Pac Portable Heating PadIRT · Traditional | Anthony A. Chiurco | 03/31/1997SE |
| K963824 | Li's Itch StopperIRT · Traditional | Hontech Foundation For Medical Technology | 12/12/1996SE |
| K962195 | Health O Meter Electric Heating Pads Models EHP2, EHP3IRT · Traditional | Sunbeam Health Division | 11/27/1996SE |
| K962252 | Health O Meter Electric Heating Pad W/Massage Model EHP4IRT · Traditional | Sunbeam Health Division | 11/25/1996SE |
| K962038 | Pes Hot/Cold CompressIRT · Traditional | Princeton Electronic Systems, Inc. | 11/13/1996SE |
| K924970 | Feminine Heat WrapIRT · Traditional | Conair Corp. | 10/03/1994SN |
| K925630 | Elastoplast Heat PlasterIRT · Traditional | Beiersdorf, Inc. | 02/25/1994SE |
| K925820 | Arthritic Heat WrapIRT · Traditional | Conair Corp. | 02/02/1994SE |
| K924885 | King Size Heat PadIRT · Traditional | Conair Corp. | 10/12/1993SE |
| K924800 | Mosist Heat Pad with Automatic OffIRT · Traditional | Conair Corp. | 10/12/1993SE |
| K924799 | Moist Heat PadIRT · Traditional | Conair Corp. | 10/12/1993SE |
| K923396 | ThermodynIRT · Traditional | Nemectron Medical, Inc. | 05/26/1993SE |
| K922089 | PneumathermIRT · Traditional | National Pain Institute | 02/23/1993SE |
| K915241 | Sports Heat WrapIRT · Traditional | Conair Corp. | 12/20/1991SE |
| K911195 | Dunlap Heat PadIRT · Traditional | Home Healthcare Products, Inc. | 08/12/1991SE |
| K903321 | Sandbox I, Sandbox II, Sandbox Jr.IRT · Traditional | Sandbox Ent. | 02/19/1991SE |
| K902895 | Infrassage MassagerIRT · Traditional | Conair Corp. | 07/25/1990SE |
| K881800 | BCS No. 1, Body Care SystemIRT · Traditional | M & A Vertrieb, Liske Und Methling GM | 11/16/1988SE |
| K882151 | Port-O-Heat, Model 0100IRT · Traditional | Arthotronics, Inc. | 11/04/1988SE |
| K881862 | Thermo-Body-Wrap SystemIRT · Traditional | Thermo Body Wrap Systems, Inc. | 10/13/1988SE |
| K873576 | Huchel BodylinerIRT · Traditional | Hans-Juergen Huchel | 01/19/1988SE |
| K873254 | Thermowrap, A/K/A/, Thermal WrapIRT · Traditional | Family Sun Tanning | 12/11/1987SE |
| K862106 | FormostarIRT · Traditional | Lmv, Liske & Methling, GmbH | 08/21/1986SE |
| K861383 | Solex Therapeutic PadIRT · Traditional | Intl. Diathermics Research, Inc. | 04/18/1986SE |
| K852637 | Thermo TrimIRT · Traditional | Suntec Health & Fitness Group, Inc. | 11/20/1985SE |
| K852604 | Muscle Minder: Heat Wrap W/ Hot + Cold PackIRT · Traditional | Clairol, Inc. | 08/12/1985SE |
| K851237 | Thermophore Electric Fomentation UnitIRT · Traditional | Battle Creek Equipment Co. | 07/29/1985SE |
| K841697 | Hydro-Thero PadIRT · Traditional | Maddak, Inc. | 05/09/1984SE |
| K841100 | HP-20, 30, 40, 50 & 60IRT · Traditional | Associated Mills, Inc. | 03/23/1984SE |
| K823301 | MicropadIRT · Traditional | Fia Man Co. | 12/03/1982SE |
| K821692 | Passive Heat PadsIRT · Traditional | Biotone International, Inc. | 07/13/1982SE |
| K801081 | Deluxe Heat Wrap/Cold WrapIRT · Traditional | The Gillette Company | 05/14/1980SE |
| K791154 | Thermal Conditioning SystemIRT · Traditional | Acurex Aerotherm | 10/09/1979SE |
| K790374 | Gillette Heat WrapIRT · Traditional | The Gillette Company | 04/10/1979SE |
| K770686 | TherathermIRT · Traditional | Electro Therapeutic Devices, Inc. | 07/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1588-2026 Class I | Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico…If heating pad is folded while in use, the power density increases in the folded area causing excessive… | Navajo Manufacturing Company | 02/18/2026Open, Classified |
| Z-2586-2024 Class II | Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24…Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a… | Eye Comfort Care LLC | 02/08/2024Completed |
| Z-0238-2023 Class I | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad…The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks… | Whele LLC DBA Perch | 10/24/2022Open, Classified |
| Z-0237-2023 Class I | Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad…The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks… | Whele LLC DBA Perch | 10/24/2022Open, Classified |
| Z-0236-2023 Class I | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks… | Whele LLC DBA Perch | 10/24/2022Open, Classified |
| Z-0349-2017 Class II | Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large…Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns. | Battle Creek Equipment Co. | 09/15/2016Terminated |
| Z-1813-2017 Class II | Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat…During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1812-2017 Class II | Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1811-2017 Class II | Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1810-2017 Class II | Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1809-2017 Class II | Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1808-2017 Class II | Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1807-2017 Class II | Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1806-2017 Class II | Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1805-2017 Class II | Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1804-2017 Class II | Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1803-2017 Class II | Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-1802-2017 Class II | Volt Resistance Heated Neck Garment Deep penetrating heat garment and wrapsDuring an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product… | 2k Innovations Inc. | 04/15/2016Terminated |
| Z-2137-2016 Class II | HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with…Products are marketed without a cleared 510k. | Ergoactives, Llc | 01/19/2016Terminated |
| Z-0626-2007 | HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off; Model No.…Heating pads may have a loose electrical connection, which could result in excessive heat being generated… | HoMedics, Inc. | 02/09/2007Terminated |
| Z-0625-2007 | HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645).Heating pads may have a loose electrical connection, which could result in excessive heat being generated… | HoMedics, Inc. | 02/09/2007Terminated |
| Z-0624-2007 | HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No.…Heating pads may have a loose electrical connection, which could result in excessive heat being generated… | HoMedics, Inc. | 02/09/2007Terminated |
| Z-0623-2007 | HoMedics Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC…Heating pads may have a loose electrical connection, which could result in excessive heat being generated… | HoMedics, Inc. | 02/09/2007Terminated |
| Z-0622-2007 | HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100 (UPC 031262003621).Heating pads may have a loose electrical connection, which could result in excessive heat being generated… | HoMedics, Inc. | 02/09/2007Terminated |