K131629 is an FDA 510(k) clearance for the NEURODYN MULTIWAVE, AUSSIE SPORT. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Ibramed Equipamentos Medicos (Aventura, US). The FDA issued a Cleared decision on November 26, 2013, 175 days after receiving the submission on June 4, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K131629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2013 |
| Decision Date | November 26, 2013 |
| Days to Decision | 175 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 |