Cleared Traditional

K974197 - ELITE LIGHTWEIGHT WHEELCHAIR

K974197 is an FDA 510(k) clearance for ELITE LIGHTWEIGHT WHEELCHAIR, manufactured by Jaken Co., Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K974197 · Jaken Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
40d
Days
Class 1
Risk

K974197 is an FDA 510(k) clearance for the ELITE LIGHTWEIGHT WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Jaken Co., Inc. (Fullerton, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 40 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 Jaken Co., Inc. devices

FDA 510(k) Submission Details - K974197

510(k) Number K974197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1997
Decision Date December 17, 1997
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
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 125
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K974197.
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
K982336 · Invacare Corp. · Aug 1998
RUNCH INDUSTRIAL WHEELCHAIR
K980107 · Runch Group USA, Inc. · Feb 1998
BREEZY SERIES
K974820 · Sunrise Medical, Inc. · Jan 1998
MECHANICAL FOLDING WHEEL CHAIR
K973491 · Heartway Medical Products Co., Ltd. · Dec 1997
QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES
K973673 · Sunrise Medical, Inc. · Nov 1997
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
K973418 · Assembly Required Dist., Inc. · Oct 1997