Cleared Traditional

K801557 - ROLLS ROLLITE WHEELCHAIR

K801557 is an FDA 510(k) clearance for ROLLS ROLLITE 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 13-day FDA review.

K801557 · Invacare Corp. · Physical Medicine device
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Jul 1980
Decision
13d
Days
Class 1
Risk

K801557 is an FDA 510(k) clearance for the ROLLS ROLLITE 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 July 21, 1980 after a review of 13 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 - K801557

510(k) Number K801557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date July 21, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
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 K801557.
PLAIN JANE SERIES WHEELCHAIR
K842232 · Invacare Corp. · Jun 1984
ULTRA-LITE PREMIER
K841830 · Everest & Jennings, Inc. · May 1984
WHEELCHAIR MECHANICAL
K840024 · Amico Lab, Inc. · Jan 1984
PORTABLE WHEELCHAIR & CARRYING CASE
K790183 · Fred Sammons, Inc. · Mar 1979
WHEELCHAIRS, MECHANICAL
K780183 · Orthopedic Equipment Co., Inc. · Feb 1978