K153696 is an FDA 510(k) clearance for the Chattanooga Revolution Wireless. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Djo, LLC (Vista, US). The FDA issued a Cleared decision on April 14, 2016, 113 days after receiving the submission on December 23, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K153696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2015 |
| Decision Date | April 14, 2016 |
| Days to Decision | 113 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 |