510(k) K251466 ยท JOW Sleeve, Limb, Compressible
VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01
| Applicant | Wellell, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Oct 28, 2025 |
| Received | May 13, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251466
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.