K223027 is an FDA 510(k) clearance for the NeuroTrigger Basic (NTB). This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Neurotrigger (Tel Aviv, IL). The FDA issued a Cleared decision on October 10, 2023, 376 days after receiving the submission on September 29, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K223027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2022 |
| Decision Date | October 10, 2023 |
| Days to Decision | 376 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |