Data / Medical devices / Infant Heel Warmer (Chemical Heat Pack) / United States
FDA-registered makers of Infant Heel Warmer (Chemical Heat Pack) in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Infant Heel Warmer (Chemical Heat Pack) (product code MPO). 4 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
- Infant Heel Warmer (Chemical Heat Pack)
- Product code
- MPO
- Country
- United States
Makers of Infant Heel Warmer (Chemical Heat Pack) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Rapid Aid Corp. | Moberly, MO, United States | Manufacturer | 2 | May 27, 2015 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Specification developer | 1 | March 18, 2016 | 0 | 1 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | January 11, 1996 | 0 | 0 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 1 | October 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pristech Products, Inc. | San Antonio, TX, 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.