Cleared Traditional

K893428 - ALPHA SHOPPER

K893428 is the FDA 510(k) clearance for ALPHA SHOPPER by Alpha Unlimited, Inc.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K893428 · Alpha Unlimited, Inc. · Physical Medicine device
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Jun 1989
Decision
41d
Days
Class 2
Risk

K893428 is an FDA 510(k) clearance for the ALPHA SHOPPER. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Alpha Unlimited, Inc. (Sarasota, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Alpha Unlimited, Inc. devices

Submission Details

510(k) Number K893428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date June 12, 1989
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 173
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K893428.
ACTION TIGER POWERED WHEELCHAIR
K930676 · Invacare Corp. · Mar 1994
MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X
K914938 · Invacare Corp. · Jan 1992
INVACARE POWER 9000 SERIES WHEELCHAIR
K900565 · Invacare Corp. · Feb 1990
ARROW MICRO COMPUTER CONTROL
K885212 · Invacare Corp. · Mar 1989
ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS
K885261 · Invacare Corp. · Mar 1989
MODEL #1551 SWITCH CONTROL INTERFACE UNIT
K880360 · Invacare Corp. · Sep 1988