The following data is part of a premarket notification filed by Lerado Oversea Ltd. Twn Branch (bvi) with the FDA for Lerado, Avanticare Transport Wheelchair, Mt-3000.
Device ID | K050707 |
510k Number | K050707 |
Device Name: | LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000 |
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 | 2005-04-18 |
Summary: | summary |