FDA device listing
TAMTEC-HANA TENS / EMS (SPORT MUSCLE STIMULATOR),TAMTEC TDR 68-4,TAMTEC TDR 68-4 PRO
FDA device listing 1291942223 · TONE-A-MATIC INTERNATIONAL, INC.
Key facts
| Proprietary names | TAMTEC-HANA TENS / EMS (SPORT MUSCLE STIMULATOR),TAMTEC TDR 68-4,TAMTEC TDR 68-4 PRO |
|---|---|
| Owner/operator | TONE-A-MATIC INTERNATIONAL, INC. |
| Owner/operator number | 9102041 |
| Premarket submissions | K143059 |
| Product codes | NGX, NUH |
| Device names | NGX - Stimulator, Muscle, Powered, For Muscle Conditioning, NUH - Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5890, 890.5850 |
| Review panels | Neurology, Physical Medicine |
| Registered establishments | TONE-A-MATIC INTERNATIONAL, INC. |
| Establishment registrations | 3006551156 |
| FEI numbers | 3006551156 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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