The following data is part of a premarket notification filed by Besteam Technology Inc. with the FDA for Landlex, Model P100x.
| Device ID | K060042 |
| 510k Number | K060042 |
| Device Name: | LANDLEX, MODEL P100X |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | BESTEAM TECHNOLOGY INC. 16F-2, NO.462, SEC. 2 CHONG-DE RD. Beitun District, Taichung, TW 40653 |
| Contact | Jeff Chang |
| Correspondent | Jeff Chang BESTEAM TECHNOLOGY INC. 16F-2, NO.462, SEC. 2 CHONG-DE 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 | 2006-01-06 |
| Decision Date | 2006-02-14 |
| Summary: | summary |