Data / Medical devices / Pack, Heat, Moist / United States
FDA-registered makers of Pack, Heat, Moist in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Pack, Heat, Moist (product code IMA). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Pack, Heat, Moist
- Product code
- IMA
- Country
- United States
Makers of Pack, Heat, Moist in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alieva SPA | Santa Fe, NM, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barbaras Development, Inc. | Thousand Oaks, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bruder Healthcare Company | Fairfield, OH, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Battle Creek Equipment | Fremont, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carolon Co. | Rural Hall, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products International Inc | Chetek, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabrication Ent., Inc. | Elmsford, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kobayashi America Manufacturing, LLC | Dalton, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaz USA, Inc., A Helen of Troy Company | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pelton Shepherd Industries | Stkn, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Physician Recommended Nutriceuticals PRN | Blue Bell, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCOPE HEALTH Inc | New York, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weslacova | North Wilkesboro, NC, United States | Contract manufacturer | 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.