510(k) K190015 ยท IRP Massager, Powered Inflatable Tube
Ballancer Gold, 1212
| Applicant | Mego Afek AC , Ltd., Kibbutz Afek, IL |
| Decision | Substantially Equivalent, Mar 25, 2019 |
| Received | Jan 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190015
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.