Cleared Traditional

K935398 - TRACER SERIES MANUAL WHEELCHAIRS

K935398 is an FDA 510(k) clearance for TRACER SERIES MANUAL WHEELCHAIRS, manufactured by Invacare Corp.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K935398 · Invacare Corp. · Physical Medicine device
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Mar 1994
Decision
112d
Days
Class 1
Risk

K935398 is an FDA 510(k) clearance for the TRACER SERIES MANUAL WHEELCHAIRS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 Corp. devices

FDA 510(k) Submission Details - K935398

510(k) Number K935398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date March 01, 1994
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 91
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K935398.
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · O'Tec Corp. · Aug 1994
STRYKER BACK-SAVER STRETCHER CHAIR MODEL 6320
K941088 · Stryker Corp. · Apr 1994
ACTION PATRIOT MANUAL WHEELCHAIR
K930803 · Invacare Corp. · Mar 1994
RECORD
K940303 · Everest & Jennings, Inc. · Feb 1994
NITRO
K940304 · Everest & Jennings, Inc. · Feb 1994
ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR
K934646 · Invacare Corp. · Dec 1993