Panels › Physical Medicine › Product code IME · Class 1
Pack, Hot Or Cold, Reusable
Regulation 890.5700
0510(k)s in 12 months (27 all time)
1recalls in 12 months (12 all time)
0recalls that name a 510(k)
Top companies in IME
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 8 |
| Fred Sammons, Inc. | 4 | 0 |
| Ackrad Laboratories | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Danek Medical, Inc. | 1 | 0 |
| Delta Medical Industries | 1 | 0 |
| DJO, LLC | 0 | 1 |
| Dr. Micheal A. Sabia | 1 | 0 |
| Ferguson Medical | 1 | 0 |
| Friendmed Products | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | DJO, LLC Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 Open, Classified |
IME | None listed |
| Nov 7, 2022 | Cardinal Health 200, LLC Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 Open, Classified |
IME | None listed |
| Dec 15, 2021 | MEDLINE INDUSTRIES, LP - Northfield CURAD REUSABLE GEL HOT/COLD PACK Open, Classified |
IME | None listed |
| Sep 16, 2019 | KT Health, LLC KT RECOVERY+ ICE/HEAT MASSAGE BALL
Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired Terminated |
IME | None listed |
| Feb 4, 2013 | Lansinoh Laboratories Inc THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box.
The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, p Terminated |
IME | None listed |
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