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Shenzhen Roundwhale Technology Co. , Ltd.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories3
Latest FDA decision2024-01-22
TypeNumberDevice NameCodeDateActions
510(k) K231423 Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)NUH2024-01-22 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; ElectrotheGXY2024-01-11 View
510(k) K231440 Combo Electrotherapy DeviceIPF2023-11-03 View
510(k) K222252 Self-adhesive ElectrodeGXY2023-01-19 View
510(k) K192087 Combo Electrotherapy DeviceNUH2019-11-01 View
510(k) K181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorIPF2018-09-07 View
510(k) K180956 Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS StimulatorNUH2018-06-07 View
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