Cleared Traditional

K851257 - CRS ULTRALITE PREMIER

K851257 is an FDA 510(k) clearance for CRS ULTRALITE PREMIER, manufactured by Everest & Jennings, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K851257 · Everest & Jennings, Inc. · Physical Medicine device
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Jun 1985
Decision
92d
Days
Class 1
Risk

K851257 is an FDA 510(k) clearance for the CRS ULTRALITE PREMIER. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 92 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 Everest & Jennings, Inc. devices

FDA 510(k) Submission Details - K851257

510(k) Number K851257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1985
Decision Date June 28, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 115d · This submission: 92d
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 123
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K851257.
2000LT WHEELCHAIR
K864901 · Invacare Corp. · Dec 1986
POIRIER MANUAL WHEELCHAIR
K864790 · Roseburg SA · Dec 1986
THE MOVER
K853424 · Invacare Corp. · Nov 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