The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Smarto.
| Device ID | K163308 |
| 510k Number | K163308 |
| Device Name: | SMARTO |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | JEIL MEDICAL CORPORATION Seoul, KR 152-728 |
| Contact | Jaehan Park |
| Correspondent | Jaehan Park JEIL MEDICAL CORPORATION Seoul, KR 152-728 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2016-12-27 |