Cleared Traditional

K850178 - DALTON FOLDING WHEELCHAIRS

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

K850178 · Dalton Instrument Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K850178

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.

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 126
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K850178.
POIRIER MANUAL WHEELCHAIR
K864790 · Roseburg SA · Dec 1986
THE MOVER
K853424 · Invacare Corp. · Nov 1985
CRS ULTRALITE PREMIER
K851257 · Everest & Jennings, Inc. · Jun 1985
PLAIN JANE SERIES WHEELCHAIR
K842232 · Invacare Corp. · Jun 1984
ULTRA-LITE PREMIER
K841830 · Everest & Jennings, Inc. · May 1984
AIRPORT WHEELCHAIR
K840633 · Poirier S.A. · Feb 1984