Data / Medical devices / Chamber, Oxygen, Topical, Extremity / United States
FDA-registered makers of Chamber, Oxygen, Topical, Extremity in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Chamber, Oxygen, Topical, Extremity (product code KPJ). 5 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
- Chamber, Oxygen, Topical, Extremity
- Product code
- KPJ
- Country
- United States
Makers of Chamber, Oxygen, Topical, Extremity in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Omarc LLC | Norwood, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | December 13, 2019 | 0 | 2 | 0 | api.fda.gov |
| Electrochemical Oxygen Concepts | San Antonio, TX, United States | Complaint file establishment, Manufacturer | 1 | August 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| GWR Medical, Inc. | Chadds Ford, PA, United States | Specification developer | 1 | November 7, 1997 | 0 | 0 | 0 | api.fda.gov |
| Numotech, Inc. | Northridge, CA, United States | Specification developer | 1 | February 3, 1999 | 0 | 0 | 0 | api.fda.gov |
| Vaporox, Inc. | Centennial, CO, United States | Complaint file establishment, Specification developer | 1 | March 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Precision Molding Ma (a Division Of Eptam Precision) | Lancaster, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, 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.