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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809315675864 | K203498 | 000 |
| 18809315675144 | K203498 | 000 |
| 08809315675130 | K203498 | 000 |
| 18809315675106 | K203498 | 000 |
| 18809315675090 | K203498 | 000 |
| 18809315675083 | K203498 | 000 |
| 18809315675076 | K203498 | 000 |
| 18809315675069 | K203498 | 000 |
| 18809315675052 | K203498 | 000 |
| 18809315675045 | K203498 | 000 |
| 18809315675038 | K203498 | 000 |
| 18809315675021 | K203498 | 000 |
| 18809315675014 | K203498 | 000 |
| 18809315675007 | K203498 | 000 |
| 18809315674994 | K203498 | 000 |
| 08809315674980 | K203498 | 000 |
| 18809315675151 | K203498 | 000 |
| 18809315675168 | K203498 | 000 |
| 08809315675178 | K203498 | 000 |
| 08809315675857 | K203498 | 000 |
| 08809315675840 | K203498 | 000 |
| 08809315675833 | K203498 | 000 |
| 08809315675291 | K203498 | 000 |
| 08809315675284 | K203498 | 000 |
| 08809315675277 | K203498 | 000 |
| 08809315675260 | K203498 | 000 |
| 08809315675253 | K203498 | 000 |
| 08809315675246 | K203498 | 000 |
| 08809315675239 | K203498 | 000 |
| 08809315675222 | K203498 | 000 |
| 08809315675215 | K203498 | 000 |
| 08809315675208 | K203498 | 000 |
| 08809315675192 | K203498 | 000 |
| 08809315675185 | K203498 | 000 |
| 18809315675120 | K203498 | 000 |