The following data is part of a premarket notification filed by Uincare Corp. with the FDA for Uincare Home.
| Device ID | K172882 |
| 510k Number | K172882 |
| Device Name: | UINCARE HOME |
| Classification | System, Optical Position/movement Recording |
| Applicant | UINCARE Corp. A-603, 131, Gasan Digital 1-ro Geumcheon-gu, KR 08506 |
| Contact | Youngbean You |
| Correspondent | Geum Hyeon Kim DT&S Co., Ltd. #1206, Mario Tower 28, Digital-ro 30-gil Guro-gu, KR 08389 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2018-05-10 |
| Summary: | summary |