The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd with the FDA for Incontinence Treatment Device, Model Lt2061.
| Device ID | K171430 |
| 510k Number | K171430 |
| Device Name: | Incontinence Treatment Device, Model LT2061 |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, XiLiBaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Contact | Truman Shen |
| Correspondent | Truman Shen Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, XiLiBaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-15 |
| Decision Date | 2018-03-15 |