FDA device listing
KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039,MZ-FM014,TENS&EMS Massager:KTR-4031, KTR-4032, KTR-4012, KTR-4015…
FDA device listing 1061784015 · Shenzhen Jie Zhong Lian Technology Co., Ltd.
Key facts
| Proprietary names | KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039,MZ-FM014,TENS&EMS Massager :KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026,TENS&EMS Massager:MZ-FM06,MZ-FM07,MZ-FM08,MZ-FM1031 |
|---|---|
| Owner/operator | Shenzhen Jie Zhong Lian Technology Co., Ltd. |
| Owner/operator number | 10085347 |
| Product codes | GZJ, IPF, NGX, NUH, NYN |
| 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, NYN - Stimulator, Electrical, Transcutaneous, For Arthritis |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5890, 890.5850 |
| Review panels | Neurology, Physical Medicine |
| Registered establishments | Shenzhen Jie Zhong Lian Technology Co., Ltd. |
| Establishment registrations | 3023339107 |
| FEI numbers | 3023339107 |
| 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