Shenzhen, CN · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Class II | Neurology | 2 | 2024-01-11 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class II | Neurology | 1 | 2024-01-22 |
| IPF | Stimulator, Muscle, Powered | Class II | Physical Medicine | 1 | 2023-11-03 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-01-22 | K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | NUH | Class II | Neurology |
| 2024-01-11 | K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe | GXY | Class II | Neurology |
| 2023-11-03 | K231440 | Combo Electrotherapy Device | IPF | Class II | Physical Medicine |
| 2023-01-19 | K222252 | Self-adhesive Electrode | GXY | Class II | Neurology |