Data / Medical devices / Pack, Hot Or Cold, Disposable / United States
FDA-registered makers of Pack, Hot Or Cold, Disposable in the United States: 57 establishments
57 establishments in the United States are registered with the FDA to make Pack, Hot Or Cold, Disposable (product code IMD). 6 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Pack, Hot Or Cold, Disposable
- Product code
- IMD
- Country
- United States
Makers of Pack, Hot Or Cold, Disposable in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Specification developer | 2 | February 3, 1994 | 0 | 3 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 1 | May 2, 1994 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | February 26, 1998 | 0 | 0 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 1 | October 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Pristech Products, Inc. | San Antonio, TX, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | February 3, 1994 | 0 | 0 | 0 | api.fda.gov |
| Rapid Aid Corp. | Moberly, MO, United States | Manufacturer | 1 | July 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| American Hospital Supply | Santa Monica, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angelini Pharma Inc. | Albany, GA, United States | Contract manufacturer, Manufacturer, Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beekley Corporation | Bristol, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bridges Consumer Healthcare | Chattanooga, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coldstar International Inc | Bristol, TN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coldventures LLC | Conshohocken, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cool Comforts LLC | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPM Solutions | South Windsor, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CorneaCare Inc | Philadelphia, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dicks Sporting Goods Inc | Coraopolis, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drmenta,inc | Albany, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enduring Brands LLC | Austin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implus Footcare LLC | Durham, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JosNoe Medical Inc | Nixa, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kinetec Usa | Jackson, WI, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kobayashi America Manufacturing, LLC | Dalton, GA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kenvue Brands LLC | Summit, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Wear Technologies, Inc. | Pompano Beach, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifeline First Aid LLC | Lake Oswego, OR, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi-Temp LLC. | Peoria, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mueller Sports Medicine, Inc. | Prairie Du Sac, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medlogix | Russia, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ncap Medical Inc | Heber City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Laboratories, Inc. | E Farmingdale, NY, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onlycare Inc | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthocor Medical Inc. | Blaine, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oasis Medical, Inc. | Glendora, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pain Relief Technologies | Sandy, UT, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pixie Cup LLC | Walnut Shade, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pain Care Labs | Atlanta, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & D Medical Products, Inc. | Lake Forest, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rain Eye Drops LLC | Wilmington, DE, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rael, Inc. | Buena Park, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safeguard Us Operating, LLC | Huntersville, NC, United States | Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Sunbeam Products, Inc. | Atlanta, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shock Doctor, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tacmed Solutions, LLC | Anderson, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Talbot's Pharmaceuticals Family Products LLC | Monroe, LA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Techtrade LLC | Orlando, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Hygenic Company, LLC | Akron, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Mentholatum Company | Orchard Park, NY, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welly Health PBC | Minneapolis, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.