Cleared Traditional

K850178 - DALTON FOLDING WHEELCHAIRS

K850178 is the FDA 510(k) clearance for DALTON FOLDING WHEELCHAIRS by Dalton Instrument Corp.. It is a Class 1 Physical Medicine device (product code IOR) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K850178 · Dalton Instrument Corp. · Physical Medicine device
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Apr 1985
Decision
98d
Days
Class 1
Risk

K850178 is an FDA 510(k) clearance for the DALTON FOLDING WHEELCHAIRS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Dalton Instrument Corp. (Richardson, US). The FDA issued a Cleared decision on April 25, 1985 after a review of 98 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 Dalton Instrument Corp. devices

Submission Details

510(k) Number K850178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1985
Decision Date April 25, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 77
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K850178.
ROLLS 2000 SERIES WHEELCHAIR
K881762 · Invacare Corp. · May 1988
2000LT WHEELCHAIR
K864901 · Invacare Corp. · Dec 1986
THE MOVER
K853424 · Invacare Corp. · Nov 1985
PLAIN JANE SERIES WHEELCHAIR
K842232 · Invacare Corp. · Jun 1984
ROLLS ROLLITE WHEELCHAIR
K801557 · Invacare Corp. · Jul 1980
PORTABLE WHEELCHAIR & CARRYING CASE
K790183 · Fred Sammons, Inc. · Mar 1979