Home › Device types › IRT
Pad, Heating, Powered
FDA product code IRT · Class 2 · Physical Medicine
993
Registered devices
6,878
Adverse events
24
Recalls
42
510(k) clearances
Devices with this code
CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDBlue Jay — COMPLETE MEDICAL SUPPLIES, INC.HOMEDICS — FKA DISTRIBUTING CO., LLCN/A — Shenzhen Osto Technology Co.,Ltd.MY MASK-E — ESPANSIONE MARKETING SPAPure Enrichment — HIVOX BIOTEK INC.Sammons Preston — Performance Health Supply, LLCCaring Mill — CARA, INCORPORATEDSunbeam — Jarden Consumer SolutionsWalgreens — WALGREEN CO.Pure Enrichment — BEAR DOWN CONSULTINGThermophore Plus — Battle Creek Equipment Co.Sunbeam — Jarden Consumer SolutionsMeijer — KAZ USA, INC.Sunmark — MCKESSON CORPORATIONThermophore Deluxe — Battle Creek Equipment Co.Pure Enrichment — BEAR DOWN CONSULTINGRITE AID — CONAIR CORPORATIONSunbeam — Jarden Consumer SolutionsTearCare iLid (TM) Device Packaged Pair - 10 pk — Sight Sciences, Inc.Mind+Body Care — KAZ USA, INC.Pure Enrichment — BEAR DOWN CONSULTINGSunbeam — Jarden Consumer SolutionsHealthyLine — Imedia Ny, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | Navajo Manufacturing Company | If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad un |
| 2024-02-08 | EYE COMFORT CARE LLC | Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short |
| 2022-10-24 | Whele LLC DBA Perch | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| 2022-10-24 | Whele LLC DBA Perch | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| 2022-10-24 | Whele LLC DBA Perch | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| 2016-09-15 | Battle Creek Equipment Co. | Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
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