ALPHA SHOPPER

Wheelchair, Powered

ALPHA UNLIMITED, INC.

The following data is part of a premarket notification filed by Alpha Unlimited, Inc. with the FDA for Alpha Shopper.

Pre-market Notification Details

Device IDK893428
510k NumberK893428
Device Name:ALPHA SHOPPER
ClassificationWheelchair, Powered
Applicant ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota,  FL  34234
ContactL Peterson
CorrespondentL Peterson
ALPHA UNLIMITED, INC. 1610 NORTHGATE BLVD. Sarasota,  FL  34234
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-02
Decision Date1989-06-12

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