Cleared Traditional

K970094 - MODEL DX MICRO COMPUTER CONTROL

K970094 is an FDA 510(k) clearance for MODEL DX MICRO COMPUTER CONTROL, manufactured by Invacare Respiratory Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K970094 · Invacare Respiratory Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
122d
Days
Class 2
Risk

K970094 is an FDA 510(k) clearance for the MODEL DX MICRO COMPUTER CONTROL. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Invacare Respiratory Corp. (Elyria, US). The FDA issued a Cleared decision on May 12, 1997 after a review of 122 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 Invacare Respiratory Corp. devices

FDA 510(k) Submission Details - K970094

510(k) Number K970094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1997
Decision Date May 12, 1997
Days to Decision 122 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
7d slower than avg
Panel avg: 115d · This submission: 122d
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 K970094.
TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT
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LIFT MASTER
K972563 · Mechanical Application Designs, Inc. · Aug 1997
ELECTRO-LITE ELITE POWERED WHEELCHAIR
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BCW POWER ADVANTAGE WHEELCHAIR
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ROLL AID
K970164 · Stand Aid of Iowa, Inc. · Apr 1997
TRX POWER TILT AND RECLINE SYSTEM
K970521 · Motion Concepts · Mar 1997