Cleared Traditional

AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) (K871391) - FDA 510(k) Clearance

Class I Physical Medicine device.

K871391 · Amigo Sales, Inc. · Physical Medicine device
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May 1987
Decision
29d
Days
Class 1
Risk

K871391 is an FDA 510(k) clearance for the AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED). Classified as Scale, Platform, Wheelchair (product code INF), Class I - General Controls.

Submitted by Amigo Sales, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 6, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3940 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amigo Sales, Inc. devices

Submission Details

510(k) Number K871391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date May 06, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INF Scale, Platform, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3940
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.