K131660 is an FDA 510(k) clearance for the SMART (SMART-D, SMART-DX). This device is classified as a Interactive Rehabilitation Exercise Devices (Class II — Special Controls, product code LXJ).
Submitted by Bts S.P.A. (Padova, IT). The FDA issued a Cleared decision on April 17, 2014, 315 days after receiving the submission on June 6, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K131660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2013 |
| Decision Date | April 17, 2014 |
| Days to Decision | 315 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 |