K232253 is an FDA 510(k) clearance for the Modius Stress. 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 Limited (Portglenone, GB). The FDA issued a Cleared decision on March 27, 2024, 243 days after receiving the submission on July 28, 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 | K232253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2023 |
| Decision Date | March 27, 2024 |
| Days to Decision | 243 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 |