510(k) K171685 ยท IRP Massager, Powered Inflatable Tube
Med4 Elite
| Applicant | Cool Systems, Inc. (Dba Game Ready), Concord CA, US |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | Jun 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171685
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.