The following data is part of a premarket notification filed by Lerado China Limited with the FDA for Lerado, Power Wheelchair, Pb.
| Device ID | K070433 |
| 510k Number | K070433 |
| Device Name: | LERADO, POWER WHEELCHAIR, PB |
| Classification | Wheelchair, Powered |
| Applicant | LERADO CHINA LIMITED NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min LERADO CHINA LIMITED 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 | 2007-02-14 |
| Decision Date | 2007-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822383291857 | K070433 | 000 |
| 00822383284217 | K070433 | 000 |
| 00822383284231 | K070433 | 000 |
| 00822383288925 | K070433 | 000 |
| 00822383289144 | K070433 | 000 |
| 00822383289151 | K070433 | 000 |
| 00822383289168 | K070433 | 000 |
| 00822383291833 | K070433 | 000 |
| 00822383291840 | K070433 | 000 |
| 06973134780237 | K070433 | 000 |