The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Corelevee.
| Device ID | K213748 |
| 510k Number | K213748 |
| Device Name: | CoreLevee |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Lutronic Corporation Lutronic Center, 219, Sowon-Ro Deogyang-Gu, Goyang-si, KR 410220 |
| Contact | Haewon Park |
| Correspondent | Haewon Park Lutronic Corporation Lutronic Center, 219, Sowon-Ro Deogyang-Gu, Goyang-si, KR 410220 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-30 |
| Decision Date | 2022-10-14 |