Cleared Traditional

NITRO

K940304 · Everest & Jennings, Inc. · Physical Medicine

Feb 1994

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K940304 is an FDA 510(k) clearance for the NITRO, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Everest & Jennings, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 17, 1994, 24 days after receiving the submission on January 24, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K940304 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1994
Decision Date	February 17, 1994
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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.