Cleared Traditional

DALTON FOLDING WHEELCHAIRS

K850178 · Dalton Instrument Corp. · Physical Medicine

Apr 1985

Decision

98d

Days

Class 1

Risk

About This 510(k) Submission

K850178 is an FDA 510(k) clearance for the DALTON FOLDING WHEELCHAIRS, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Dalton Instrument Corp. (Richardson, US). The FDA issued a Cleared decision on April 25, 1985, 98 days after receiving the submission on January 17, 1985. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K850178 FDA.gov
FDA Decision	Cleared 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	—

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — 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.