The following data is part of a premarket notification filed by Lerado China Limited with the FDA for Avanticare, Model Sa4021.
| Device ID | K060068 |
| 510k Number | K060068 |
| Device Name: | AVANTICARE, MODEL SA4021 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | LERADO CHINA LIMITED CHONGDE RD., BEITUN DISTRICT Taichung, TW 40653 |
| Contact | Jeff Chang |
| Correspondent | Jeff Chang LERADO CHINA LIMITED CHONGDE RD., BEITUN DISTRICT Taichung, TW 40653 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-09 |
| Decision Date | 2006-03-08 |
| Summary: | summary |