510(k) K161154 ยท NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
| Applicant | Spr Therapeutics, LLC, Cleveland OH, US |
| Decision | Substantially Equivalent, Jul 23, 2016 |
| Received | Apr 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161154
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.