Data / Medical devices / Unit, Chilling
Unit, Chilling (IMF): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Unit, Chilling (product code IMF, Class 1, 21 CFR 890.5940). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on February 27, 1990, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IMF
- Device class
- 1
- Regulation
- 890.5940
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Mexico | 1 |
| Japan | 1 |
| Pakistan | 1 |
Makers of Unit, Chilling
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 |
|---|---|---|---|---|---|---|---|---|
| CSafe Global | Dayton, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Quanding Medical Supplies Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kiyou Jochugiku | Kainan Wakayama, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linjiang (holdings) Limited | Shangqiu Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nadir & Co. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen City U-Lucky Sporting Goods Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tryptech Services | Greensboro, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WEG Surgical Solutions | Greensboro, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 27, 1990. 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.