K230826 is an FDA 510(k) clearance for the Modius Sleep. This device is classified as a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II - Special Controls, product code QJQ).
Submitted by Neurovalens , Ltd. (Portglenone, GB). The FDA issued a Cleared decision on October 27, 2023, 217 days after receiving the submission on March 24, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5800. To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety.
| 510(k) Number | K230826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QJQ - Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5800 |
| Definition | To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety |