Cleared Traditional

K994241 - TRX-CG POWER TILT AND RECLINE SYSTEM

K994241 is an FDA 510(k) clearance for TRX-CG 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 29-day FDA review.

K994241 · Motion Concepts · Physical Medicine device
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Jan 2000
Decision
29d
Days
Class 2
Risk

K994241 is an FDA 510(k) clearance for the TRX-CG 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 January 13, 2000 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 890.3860 - 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 - K994241

510(k) Number K994241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1999
Decision Date January 13, 2000
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 K994241.
E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER
K992828 · Accelerated Rehab Designs, Inc. · Feb 2000
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AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
K994107 · Amylior, Inc. · Jan 2000
RTD ARM ASSISTIVE ROBOTIC DEVICE
K993443 · Rehabilitation Technologies Division · Dec 1999
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K993413 · Invacare Corp. · Dec 1999
OMEGA TRAC, MODEL Z100
K993160 · Teftec Corp. · Nov 1999