510(k) K151296 ยท PBX Massager, Vacuum, Radio Frequency Induced Heat
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
| Applicant | Bios S.R.L., Vimodrone, IT |
| Decision | Substantially Equivalent, Nov 19, 2015 |
| Received | May 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2017 | Bios S.r.l. THERMI250 Radiofrequency System.
Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions. Terminated |
PBX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.