The following data is part of a premarket notification filed by Lerado Global (macao Commercial Offshore) Limited with the FDA for Lerado, Power Wheelchair.
| Device ID | K130982 |
| 510k Number | K130982 |
| Device Name: | LERADO, POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | LERADO GLOBAL (MACAO COMMERCIAL OFFSHORE) LIMITED AVENIDA MARCIANO BAOTISTA, NO. 26-54B, 7 ANDAR H7 EDIF. CENTRO COM. CHONG FOK Macau, CN Ch |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min LERADO GLOBAL (MACAO COMMERCIAL OFFSHORE) LIMITED AVENIDA MARCIANO BAOTISTA, NO. 26-54B, 7 ANDAR H7 EDIF. CENTRO COM. CHONG FOK Macau, CN Ch |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-09 |
| Decision Date | 2014-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973134780039 | K130982 | 000 |