510(k) K251446 ยท JOW Sleeve, Limb, Compressible
PlasmaFlow X Compression Sleeve Device (XPF0001)
| Applicant | Manamed, LLC, Denton TX, US |
| Decision | Substantially Equivalent, Sep 17, 2025 |
| Received | May 9, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251446
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.