510(k) K260944 ยท IRP Massager, Powered Inflatable Tube
ManaCold Compression System
| Applicant | Manamed, LLC, Denton TX, US |
| Decision | Substantially Equivalent, Aug 12, 2026 |
| Received | Mar 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260944
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.