The following data is part of a premarket notification filed by Daesung Maref Co., Ltd with the FDA for Sp-1000, Sp-2000.
| Device ID | K202395 |
| 510k Number | K202395 |
| Device Name: | SP-1000, SP-2000 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si, KR 15809 |
| Contact | Hyoung Ju Cho |
| Correspondent | Do Gyun Lim Global Medical Standard Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu Seoul, KR 03909 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809315672020 | K202395 | 000 |
| 18809315672419 | K202395 | 000 |
| 18809315672402 | K202395 | 000 |
| 18809315672396 | K202395 | 000 |
| 18809315672389 | K202395 | 000 |
| 18809315672372 | K202395 | 000 |
| 18809315672303 | K202395 | 000 |
| 18809315672297 | K202395 | 000 |
| 18809315672280 | K202395 | 000 |
| 18809315672273 | K202395 | 000 |
| 18809315672266 | K202395 | 000 |
| 18809315672259 | K202395 | 000 |
| 18809802640679 | K202395 | 000 |
| 18809802640686 | K202395 | 000 |
| 18809802640693 | K202395 | 000 |
| 18809315672013 | K202395 | 000 |
| 18809315672006 | K202395 | 000 |
| 18809315671993 | K202395 | 000 |
| 18809315671986 | K202395 | 000 |
| 18809315671917 | K202395 | 000 |
| 18809315671900 | K202395 | 000 |
| 18809315671894 | K202395 | 000 |
| 18809315671887 | K202395 | 000 |
| 18809315671870 | K202395 | 000 |
| 18809315671863 | K202395 | 000 |
| 08809315671859 | K202395 | 000 |
| 08809315672245 | K202395 | 000 |