Cleared Traditional

K001298 - J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR

K001298 is an FDA 510(k) clearance for J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR, manufactured by Roll-Ability (Pty) , Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K001298 · Roll-Ability (Pty) , Ltd. · Physical Medicine device
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Jul 2000
Decision
85d
Days
Class 1
Risk

K001298 is an FDA 510(k) clearance for the J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Roll-Ability (Pty) , Ltd. (Roanoke, US). The FDA issued a Cleared decision on July 18, 2000 after a review of 85 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.

FDA 510(k) Submission Details - K001298

510(k) Number K001298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2000
Decision Date July 18, 2000
Days to Decision 85 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 116d · This submission: 85d
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 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K001298.
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · Invacare Corp. · Aug 2000
BONUS MECHANICAL WHEELCHAIR
K001391 · Bonus Ent. Corp. · Jul 2000
SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)
K001890 · Otto Bock Orthopaedische Industrie, Kg. · Jul 2000
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
K001252 · Maxhealth Corp. · Jun 2000
WHEELCHAIR, MODELS H001A, 4422
K000738 · Jackson Company, LLC · May 2000
VOYAGER/VIPER WHEELCHAIR
K000497 · Otto Bock Orthopedic Industry, Inc. · Mar 2000
K001298 · J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR
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