510(k) K213210 ยท CAW Generator, Oxygen, Portable
Oxygen Concentrator, Model JAY-5AW
| Applicant | Longfian Scitech Co., Ltd., Baoding, CN |
| Decision | Substantially Equivalent, Dec 8, 2022 |
| Received | Sep 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2026 | 3B Medical, Inc. React Health PHOENIX 5L Oxygen Concentrator Open, Classified |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.