Cleared Traditional

K972564 - TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT

K972564 is an FDA 510(k) clearance for TILT MASTER CG SYSTEM (CENTER OF GRAVITY), manufactured by Mechanical Application Designs, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K972564 · Mechanical Application Designs, Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
47d
Days
Class 2
Risk

K972564 is an FDA 510(k) clearance for the TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Mechanical Application Designs, Inc. (Katy, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 47 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 Mechanical Application Designs, Inc. devices

FDA 510(k) Submission Details - K972564

510(k) Number K972564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1997
Decision Date August 25, 1997
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
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 287
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K972564.
QUICKIE P90 SERIES
K972230 · Quickie Designs, Inc. · Dec 1997
RASCAL POWER CHAIR
K972370 · Electric Mobility Corp. · Nov 1997
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)
K972147 · Dynamic Systems, Inc. · Aug 1997
LIFT MASTER
K972563 · Mechanical Application Designs, Inc. · Aug 1997
ELECTRO-LITE ELITE POWERED WHEELCHAIR
K970575 · Damaco · Aug 1997
MODEL DX MICRO COMPUTER CONTROL
K970094 · Invacare Respiratory Corp. · May 1997