Home › PAIN POINT MEDICAL SYSTEMS INC. › MiBo Heating Pad Mask
MiBo Heating Pad Mask
PAIN POINT MEDICAL SYSTEMS INC. · Model 3936275 · UDI-DI 00869086000317
10
510(k) clearances
6,878
Adverse events (12 deaths)
24
Recalls
274
Facilities
Description
Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes.
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 under the body, then t |
| 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 in the heating eleme |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.