The following data is part of a premarket notification filed by Ibramed Equipamentos Medicos with the FDA for Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator.
| Device ID | K121369 |
| 510k Number | K121369 |
| Device Name: | NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| Subsequent Product Code | GZI |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-12-19 |
| Summary: | summary |