Data / Medical devices / United States / Oxus America, Inc.
Oxus America, Inc.: FDA-registered device maker in Orion Township, MI, United States, 1 510(k) clearance
Oxus America, Inc. is registered with the FDA (registration 3008841036) in Orion Township, MI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 31, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008841036
- Address
- 175 Kay Industrial Drive, Orion Township, MI, United States, 48359
- Owner or operator
- Oxus America Inc (10033183)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 13, 2023
- Registered through
- 2027
- Brand names listed
- Oxus Sieve Beds
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 31, 2023 | K211056 | Oxus Sieve Beds | CAW | Substantially Equivalent | Oxus, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 14, 2013 | 64057 | Class II | Terminated | Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with | Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells. | accessdata.fda.gov |
Compare with other makers
Updated May 31, 2023. 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.