510(k) K261887 ยท IRP Massager, Powered Inflatable Tube
Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)
| Applicant | NormaTec Industries, LP, Watertown MA, US |
| Decision | Substantially Equivalent, Oct 6, 2026 |
| Received | Jun 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261887
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.