The following data is part of a premarket notification filed by Alpha Unlimited, Inc. with the FDA for Alpha Shopper.
Device ID | K893428 |
510k Number | K893428 |
Device Name: | ALPHA SHOPPER |
Classification | Wheelchair, Powered |
Applicant | ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota, FL 34234 |
Contact | L Peterson |
Correspondent | L Peterson ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota, FL 34234 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-02 |
Decision Date | 1989-06-12 |