Shenzhen Roundwhale Technology Co. , Ltd. · Class II · Cleared Jan 22, 2024
| K-number | K231423 |
| Device name | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) |
| Applicant | Shenzhen Roundwhale Technology Co. , Ltd. |
| Product code | NUH |
| Device class | Class II |
| Decision date | Jan 22, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 882.5890 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov