Cleared Traditional

K000174 - ACTION AF-1 WHEELCHAIR

K000174 is an FDA 510(k) clearance for ACTION AF-1 WHEELCHAIR, 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 29-day FDA review.

K000174 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
29d
Days
Class 1
Risk

K000174 is an FDA 510(k) clearance for the ACTION AF-1 WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on February 18, 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 890.3850 - 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: 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 Invacare Corp. devices

FDA 510(k) Submission Details - K000174

510(k) Number K000174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2000
Decision Date February 18, 2000
Days to Decision 29 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
87d faster than avg
Panel avg: 116d · This submission: 29d
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 312
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K000174.
WHEELCHAIR, MODELS H001A, 4422
K000738 · Jackson Company, LLC · May 2000
VOYAGER/VIPER WHEELCHAIR
K000497 · Otto Bock Orthopedic Industry, Inc. · Mar 2000
PROTEGE WHEELCHAIR
K000602 · Otto Bock Orthopedic Industry, Inc. · Mar 2000
SIGMA MANUAL WHEELCHAIR
K993963 · Sigma Distribution & Supply, Inc. · Jan 2000
MANUAL WHEELCHAIR
K994185 · Major Mobility Products, Inc. · Jan 2000
E Z CHAIR
K993298 · Premier Designs · Nov 1999