The following data is part of a premarket notification filed by Lerado Oversea Ltd. Twn Branch (bvi) with the FDA for Lerado Avanticare Power Wheelchair, Model Pw-1800.
| Device ID | K050087 |
| 510k Number | K050087 |
| Device Name: | LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800 |
| Classification | Wheelchair, Powered |
| Applicant | LERADO OVERSEA LTD. TWN BRANCH (BVI) NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen LERADO OVERSEA LTD. TWN BRANCH (BVI) NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-13 |
| Decision Date | 2005-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822383292847 | K050087 | 000 |
| 06973134780275 | K050087 | 000 |