FDA 510(k) Applications Submitted by Shenzhen Roundwhale Technology Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180956 |
04/12/2018 |
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator |
Shenzhen Roundwhale Technology Co., Ltd. |
| K181688 |
06/26/2018 |
R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator |
Shenzhen Roundwhale Technology Co., Ltd. |
| K192087 |
08/05/2019 |
Combo Electrotherapy Device |
Shenzhen Roundwhale Technology Co., Ltd. |
| K231440 |
05/18/2023 |
Combo Electrotherapy Device |
Shenzhen Roundwhale Technology Co., Ltd. |
| K222252 |
07/27/2022 |
Self-adhesive Electrode |
Shenzhen Roundwhale Technology Co., Ltd. |
| K232995 |
09/22/2023 |
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; El |
Shenzhen Roundwhale Technology Co., Ltd. |
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