K171547 is an FDA 510(k) clearance for the Qualisys Clinical System. This device is classified as a Interactive Rehabilitation Exercise Devices (Class II - Special Controls, product code LXJ).
Submitted by Qualisys AB (Goteborg, SE). The FDA issued a Cleared decision on August 2, 2018, 433 days after receiving the submission on May 26, 2017.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K171547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2017 |
| Decision Date | August 02, 2018 |
| Days to Decision | 433 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | LXJ — Interactive Rehabilitation Exercise Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |