FDA device listing
TENS&EMS Units (SM9109A, SM9109B),Wireless Muscle Stimulator (SM9109A, SM9109B)
FDA device listing 1639922414 · Hong Qiangxing (Shen Zhen) Electronics Limited
Key facts
| Proprietary names | TENS&EMS Units (SM9109A, SM9109B),Wireless Muscle Stimulator (SM9109A, SM9109B) |
|---|---|
| Owner/operator | Hong Qiangxing (Shen Zhen) Electronics Limited |
| Owner/operator number | 10044280 |
| 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 | HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
| Establishment registrations | 3010402752 |
| FEI numbers | 3010402752 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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