The following data is part of a premarket notification filed by Well Success Biotech Inc. with the FDA for A&i Scooter, Sc-301.
| Device ID | K041187 |
| 510k Number | K041187 |
| Device Name: | A&I SCOOTER, SC-301 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | WELL SUCCESS BIOTECH INC. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min WELL SUCCESS BIOTECH INC. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-06 |
| Decision Date | 2004-05-25 |
| Summary: | summary |