FDA device listing
AHC-T7K,Combo Electrotherapy Device (Model: R-C101C, R-C101D, R-C101F, R-C101G,F100, MINI TENS…
FDA device listing 2058191520 · Shenzhen Roundwhale Technology Co. Ltd.
Key facts
| Proprietary names | AHC-T7K,Combo Electrotherapy Device (Model: R-C101C, R-C101D, R-C101F, R-C101G,F100, MINI TENS COMB,R-C101I,TENS3500,R-C101K),Doctor's Choice® TENS 3MT, TENS 3MT,ISTIM SOOTHE 1,ME 89+,R-C112B,TENS 12MT,TENS 12MT OTC,ePower®T1,ePower®T2,TENSnet 3MT,ePower®TE2 |
|---|---|
| Owner/operator | Shenzhen Roundwhale Technology Co. Ltd. |
| Owner/operator number | 10057039 |
| Premarket submissions | K231423 |
| Product codes | GZJ, IPF, NGX, NUH |
| Device names | GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief, IPF - Stimulator, Muscle, Powered, 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 ROUNDWHALE TECHNOLOGY CO. LTD. |
| Establishment registrations | 3014314933 |
| FEI numbers | 3014314933 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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