Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list 2k Innovations with 12 device recalls. The most recent is a device recall dated Apr 15, 2016: Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 15, 2016 | Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
| Apr 15, 2016 | Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
| Apr 15, 2016 | Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
| Apr 15, 2016 | Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
| Apr 15, 2016 | Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
| Apr 15, 2016 | Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
| Apr 15, 2016 | Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
| Apr 15, 2016 | Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wrapsClass II · During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
