The following data is part of a premarket notification filed by Lerado Oversea Ltd. Twn Branch (bvi) with the FDA for Lerado, Avanticare Mechanical Wheelchair, Mr-9000.
| Device ID | K050708 |
| 510k Number | K050708 |
| Device Name: | LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 |
| Classification | Wheelchair, Mechanical |
| Applicant | LERADO OVERSEA LTD. TWN BRANCH (BVI) NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min LERADO OVERSEA LTD. TWN BRANCH (BVI) NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-04-26 |
| Summary: | summary |