Cleared Traditional

K963808 - CHOICE POWERED WHEELCHAIR

K963808 is an FDA 510(k) clearance for CHOICE POWERED WHEELCHAIR, manufactured by American Medical Technology, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K963808 · American Medical Technology, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
142d
Days
Class 2
Risk

K963808 is an FDA 510(k) clearance for the CHOICE POWERED WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by American Medical Technology, Inc. (Canton, US). The FDA issued a Cleared decision on February 12, 1997 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Technology, Inc. devices

FDA 510(k) Submission Details - K963808

510(k) Number K963808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date February 12, 1997
Days to Decision 142 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

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 375
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K963808.
ROLL AID
K970164 · Stand Aid of Iowa, Inc. · Apr 1997
TRX POWER TILT AND RECLINE SYSTEM
K970521 · Motion Concepts · Mar 1997
POWERED WHEELCHAIR
K962565 · Orthofab, Inc. · Mar 1997
CHIPS STANDUP WHEELCHAIR
K955547 · International Healthcare Solutions, Inc. · Sep 1996
CHIPS POWERED WHEELCHAIR
K955548 · International Healthcare Solutions, Inc. · Sep 1996
HELPING HAND
K954427 · Kinetic Rehabilitation Instruments, Inc. · Sep 1996