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AVACEN MEDICAL, INC · Model AVACEN HOME XL 5-YEAR · UDI-DI 00862800000396
1
510(k) clearances
6,882
Adverse events (12 deaths)
24
Recalls
274
Facilities
Description
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
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. |
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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.