The following data is part of a premarket notification filed by Zhejiang Qiangnao Technology Co.,ltd with the FDA for Dexus Prosthetics System (model: Msl1, Msr1).
| Device ID | K220002 |
| 510k Number | K220002 |
| Device Name: | Dexus Prosthetics System (Model: MSL1, MSR1) |
| Classification | Electrode, Cutaneous |
| Applicant | Zhejiang Qiangnao Technology Co.,Ltd Room 201-5, Building 1, No.1818-2, Wenyi West Road Yuhang Street, Yuhang District Hangzhou, CN 310000 |
| Contact | Boyuan Meng |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, CN 510000 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-04 |
| Decision Date | 2022-09-09 |