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Data / Medical devices / Chamber, Oxygen, Topical, Extremity

Chamber, Oxygen, Topical, Extremity (KPJ): 17 FDA-registered makers in 4 countries

17 establishments in 4 countries are registered with the FDA to make Chamber, Oxygen, Topical, Extremity (product code KPJ, Class 2, 21 CFR 878.5650). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on March 10, 2025, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KPJ
Device class
2
Regulation
878.5650
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States12
Mexico3
Ireland1
United Kingdom1

Makers of Chamber, Oxygen, Topical, Extremity

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aoti Ltd.GALWAY Galway(County), IrelandComplaint file establishment, Manufacturer2August 6, 2008000api.fda.gov
Omarc LLCNorwood, MA, United StatesComplaint file establishment, Manufacturer, Specification developer2December 13, 2019020api.fda.gov
Electrochemical Oxygen ConceptsSan Antonio, TX, United StatesComplaint file establishment, Manufacturer1August 12, 2009000api.fda.gov
GWR Medical, Inc.Chadds Ford, PA, United StatesSpecification developer1November 7, 1997000api.fda.gov
Inotec Amd Ltd.Cambridge Cambridgeshire, United KingdomManufacturer1July 3, 2012000api.fda.gov
Numotech, Inc.Northridge, CA, United StatesSpecification developer1February 3, 1999000api.fda.gov
Vaporox, Inc.Centennial, CO, United StatesComplaint file establishment, Specification developer1March 10, 2025000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesSpecification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Eptam Precision Molding Ma (a Division Of Eptam Precision)Lancaster, MA, United StatesContract manufacturer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Ipax, Inc.Englewood, CO, United StatesContract manufacturer0000api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
Salter Labs de Mexico de S.A. de C.V.Chihuahua Mexico, MexicoContract manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov

Updated March 10, 2025. 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.