Cleared Traditional

K823085 - BERKELEY CHAIR

K823085 is an FDA 510(k) clearance for BERKELEY CHAIR, manufactured by Berkeley Electric Wheelchair Co.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K823085 · Berkeley Electric Wheelchair Co. · Physical Medicine device
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Jan 1983
Decision
94d
Days
Class 2
Risk

K823085 is an FDA 510(k) clearance for the BERKELEY CHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Berkeley Electric Wheelchair Co. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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.

FDA 510(k) Submission Details - K823085

510(k) Number K823085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1982
Decision Date January 21, 1983
Days to Decision 94 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
22d faster than avg
Panel avg: 116d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 592
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K823085.
PREMIER
K834552 · Everest & Jennings, Inc. · Jan 1984
OC3 FLYER
K832745 · Intl. Medical Equipment Corp. · Sep 1983
BASE ONLY, POWER WHEELCHAIR
K832325 · Intl. Medical Equipment Corp. · Aug 1983
HITCH HIKER
K823117 · Amigo Sales, Inc. · Nov 1982
SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER
K823175 · Kinetic Concepts, Inc. · Nov 1982
POWER DRIVE WHEELCR
K813104 · Intl. Medical Equipment Corp. · Nov 1981
K823085 · BERKELEY CHAIR
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