K080545 is an FDA 510(k) clearance for the ACTITRAINER. This device is classified as a Exerciser, Measuring (Class II - Special Controls, product code ISD).
Submitted by Actigraph, LLC (Pensacola, US). The FDA issued a Cleared decision on July 24, 2008, 148 days after receiving the submission on February 27, 2008.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K080545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2008 |
| Decision Date | July 24, 2008 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISD - Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |