FDA device listing
NEURODYN PORTABLE TENS,NEURODYN PORTABLE TENS NFES,NEUROTONUS PORTABLE TENS,NEUROTONUS PORTABLE TENS FES
FDA device listing 1697988270 · Ibramed Industria Brasileira de Equipamentos Medicos Ltda
Key facts
| Proprietary names | NEURODYN PORTABLE TENS,NEURODYN PORTABLE TENS NFES,NEUROTONUS PORTABLE TENS,NEUROTONUS PORTABLE TENS FES |
|---|---|
| Owner/operator | Ibramed Industria Brasileira de Equipamentos Medicos Ltda |
| Owner/operator number | 10043478 |
| Premarket submissions | K131923 |
| Product codes | GZI, GZJ |
| Device names | GZI - Stimulator, Neuromuscular, External Functional, GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5810, 882.5890 |
| Review panels | Neurology |
| Registered establishments | Ibramed Industria Brasileira de Equipamentos Medicos Ltda |
| Establishment registrations | 3010362721 |
| FEI numbers | 3010362721 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database