Cleared Traditional

K970521 - TRX POWER TILT AND RECLINE SYSTEM

K970521 is an FDA 510(k) clearance for TRX POWER TILT AND RECLINE SYSTEM, manufactured by Motion Concepts. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K970521 · Motion Concepts · Physical Medicine device
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Mar 1997
Decision
48d
Days
Class 2
Risk

K970521 is an FDA 510(k) clearance for the TRX POWER TILT AND RECLINE SYSTEM. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Motion Concepts (Toronto, Ontario, CA). The FDA issued a Cleared decision on March 31, 1997 after a review of 48 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 Motion Concepts devices

FDA 510(k) Submission Details - K970521

510(k) Number K970521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date March 31, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
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 K970521.
QUICKIE P100 SERIES
K963382 · Quickie Designs, Inc. · Apr 1997
QUICKIE POWER WHEELCHAIRS P200 SERIES
K963385 · Quickie Designs, Inc. · Apr 1997
ROLL AID
K970164 · Stand Aid of Iowa, Inc. · Apr 1997
POWERED WHEELCHAIR
K962565 · Orthofab, Inc. · Mar 1997
CHOICE POWERED WHEELCHAIR
K963808 · American Medical Technology, Inc. · Feb 1997
CHIPS STANDUP WHEELCHAIR
K955547 · International Healthcare Solutions, Inc. · Sep 1996