FDA device listing
ENS and Muscle Stimulator (IonMedX; VitaMed),TENS AND EMS (PRO 1200),TENS AND EMS (TENS and Muscle Stimulator) (JT8012C…
FDA device listing 1747820294 · Shenzhen Jiantuo Electronics Co., Ltd
Key facts
| Proprietary names | ENS and Muscle Stimulator (IonMedX; VitaMed),TENS AND EMS (PRO 1200),TENS AND EMS (TENS and Muscle Stimulator) (JT8012C, JT8016, JT9020E, JT9026, AS9026, JT9022, 2508),Tens and Muscle Stimulator AS2015 (TE2017 / VERVE, DTE2017 / VERVE Deluxe),TENS UNIT PRO 1000 |
|---|---|
| Owner/operator | Shenzhen Jiantuo Electronics Co., Ltd |
| Owner/operator number | 10093000 |
| Premarket submissions | K250360 |
| 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 | SHENZHEN JIANTUO ELECTRONICS CO., LTD |
| Establishment registrations | 3038195193 |
| FEI numbers | 3038195193 |
| Establishment operations | Foreign Exporter, 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