510(k) K253555 · JOW Sleeve, Limb, Compressible
Flexitouch® Plus Advanced Pneumatic Compression System
| Applicant | Tactile Medical, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 31, 2026 |
| Received | Nov 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253555
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.