510(k) K062284 ยท QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
CES ULTRA
| Applicant | Neuro-Fitness, LLC, Snoqualmie WA, US |
| Decision | Substantially Equivalent, Apr 5, 2007 |
| Received | Aug 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2008 | Neuro-Fitness LLC CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024 Terminated |
JXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.