The following data is part of a premarket notification filed by Ibramed Equipamentos Medicos with the FDA for Neurodyn Multiwave, Aussie Sport.
| Device ID | K131629 |
| 510k Number | K131629 |
| Device Name: | NEURODYN MULTIWAVE, AUSSIE SPORT |
| Classification | Stimulator, Muscle, Powered |
| Applicant | IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Contact | Lilian Llull |
| Correspondent | Lilian Llull IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Product Code | IPF |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2013-11-26 |
| Summary: | summary |