The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Lf900.
| Device ID | K203019 |
| 510k Number | K203019 |
| Device Name: | LF900 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si, KR 15809 |
| Contact | So Su Hyeon |
| Correspondent | So Su Hyeon DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si, KR 15809 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2021-06-22 |