K123354 is an FDA 510(k) clearance for the REVITIVE IX. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Actegy , Ltd. (Washington, US). The FDA issued a Cleared decision on June 28, 2013, 240 days after receiving the submission on October 31, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K123354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2012 |
| Decision Date | June 28, 2013 |
| Days to Decision | 240 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 |