Shenzhen Roundwhale Technology Co. , Ltd.
FDA 510(k) & PMA Approved Devices — 7 products
Total Devices7
Categories3
Latest Approval2024-01-22
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | NUH | 2024-01-22 | View |
| 510(k) | 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 | 2024-01-11 | View |
| 510(k) | K231440 | Combo Electrotherapy Device | IPF | 2023-11-03 | View |
| 510(k) | K222252 | Self-adhesive Electrode | GXY | 2023-01-19 | View |
| 510(k) | K192087 | Combo Electrotherapy Device | NUH | 2019-11-01 | View |
| 510(k) | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | IPF | 2018-09-07 | View |
| 510(k) | K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator | NUH | 2018-06-07 | View |
No matching devices.