K231532 is an FDA 510(k) clearance for the ActiGraph LEAP activity monitor (ActiGraph LEAP). This device is classified as a Device, Sleep Assessment (Class II - Special Controls, product code LEL).
Submitted by Actigraph, LLC (Pensacola, US). The FDA issued a Cleared decision on June 23, 2023, 28 days after receiving the submission on May 26, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K231532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2023 |
| Decision Date | June 23, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LEL - Device, Sleep Assessment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |