510(k) K991241 ยท IPF Stimulator, Muscle, Powered
IF8000
| Applicant | Dan Med, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Nov 2, 1999 |
| Received | Apr 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991241
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2014 | Zynex Medical, Inc. IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode.
Designed for use in physical therapy, rehabilitation, and pain relief applications. Terminated |
IPF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.