The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Levator Elite (model Le9011).
| Device ID | K213043 |
| 510k Number | K213043 |
| Device Name: | Levator Elite (Model LE9011) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Shenzhen Dongdixin Technology Co., Ltd. Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, CN 518108 |
| Contact | Siping Yuan |
| Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co., Ltd. Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, CN 518108 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| 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 | 2021-09-22 |
| Decision Date | 2022-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00092237624456 | K213043 | 000 |