The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for Lx9max.
| Device ID | K203498 |
| 510k Number | K203498 |
| Device Name: | LX9max |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Daesung Maref CO., LTD. 298-24, Gongdan-Ro Gunpo-si, KR 15809 |
| Contact | Su Hyeon So |
| Correspondent | Su Hyeon So 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 | 2020-11-27 |
| Decision Date | 2021-07-02 |