Data / Medical devices / Infant Heel Warmer (Chemical Heat Pack)
Infant Heel Warmer (Chemical Heat Pack) (MPO): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Infant Heel Warmer (Chemical Heat Pack) (product code MPO, Class 1, 21 CFR 890.5710). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on October 7, 2022, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MPO
- Device class
- 1
- Regulation
- 890.5710
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 2 |
| Vietnam | 2 |
| Canada | 1 |
| Taiwan | 1 |
Makers of Infant Heel Warmer (Chemical Heat Pack)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd | Danyang Jiangsu, China | Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 2 | May 27, 2015 | 0 | 0 | 0 | api.fda.gov |
| Rapid Aid Corp. | MISSISSAUGA Ontario, Canada | Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 2 | May 27, 2015 | 0 | 0 | 0 | api.fda.gov |
| Rapid Aid Corp. | Moberly, MO, United States | Manufacturer | 2 | May 27, 2015 | 0 | 0 | 0 | api.fda.gov |
| Rapid Aid Vietnam Co., Ltd | An Quang Commune Hai Phong, Vietnam | Complaint file establishment, Exporter to the US, 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 |
| Intco Medical Technology Viet Nam Company Limited | Dong Mai Ward Quang Ninh, Vietnam | Manufacturer | 1 | September 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 1 | October 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Intco Medical Products Co., Ltd. | Zhenjiang New District Jiangsu, China | Manufacturer | 1 | September 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ten Comfort Corp. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | October 22, 2003 | 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 October 7, 2022. 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.