The following data is part of a premarket notification filed by Alpha Unlimited, Inc. with the FDA for Alpha Super Kart.
| Device ID | K853766 |
| 510k Number | K853766 |
| Device Name: | ALPHA SUPER KART |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota, FL 34234 |
| Contact | Penny Lockett |
| Correspondent | Penny Lockett ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota, FL 34234 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1985-11-20 |