The following data is part of a premarket notification filed by Medlander Medical Technology Inc. with the FDA for Biological Feedback And Stimulation System.
| Device ID | K222201 |
| 510k Number | K222201 |
| Device Name: | Biological Feedback And Stimulation System |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Medlander Medical Technology Inc. Building 5, Acceleration Zone, Nanjing Life Science And Technology, Innovation Park Nanjing, CN 211100 |
| Contact | Wang Wang |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, CN 518067 |
| Product Code | IPF |
| Subsequent Product Code | HCC |
| Subsequent Product Code | KPI |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-10-21 |