Shenzhen Roundwhale Technology Co. , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101 | January 22, 2024 |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscl | January 11, 2024 |
| K231440 | Combo Electrotherapy Device | November 3, 2023 |
| K222252 | Self-adhesive Electrode | January 19, 2023 |
| K192087 | Combo Electrotherapy Device | November 1, 2019 |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | September 7, 2018 |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TE | June 7, 2018 |