Cleared Traditional

PREMIER CLASSIC

K930413 · Everest & Jennings, Inc. · Physical Medicine

Mar 1993

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K930413 is an FDA 510(k) clearance for the PREMIER CLASSIC, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Everest & Jennings, Inc. (Earth City, US). The FDA issued a Cleared decision on March 31, 1993, 64 days after receiving the submission on January 26, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K930413 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1993
Decision Date	March 31, 1993
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

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.