Shenzhen Roundwhale Technology Co. , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500), Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005, Combo Electrotherapy Device
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Roundwhale Technology Co. , Ltd. Neurology ✕
5 devices
Cleared
Jan 22, 2024
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G,...
Neurology
250d
Cleared
Jan 11, 2024
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode...
Neurology
111d
Cleared
Jan 19, 2023
Self-adhesive Electrode
Neurology
176d
Cleared
Nov 01, 2019
Combo Electrotherapy Device
Neurology
88d
Cleared
Jun 07, 2018
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS...
Neurology
56d