Cleared Traditional

CORNER SEAT (K894767) - FDA 510(k) Clearance

Class I Physical Medicine device.

K894767 · Canadian Posture and Seating Centre, Inc. · Physical Medicine device
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Jan 1990
Decision
175d
Days
Class 1
Risk

K894767 is an FDA 510(k) clearance for the CORNER SEAT. Classified as Chair, Adjustable, Mechanical (product code INN), Class I - General Controls.

Submitted by Canadian Posture and Seating Centre, Inc. (Canada N2g 4p2, CA). The FDA issued a Cleared decision on January 17, 1990 after a review of 175 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3100 - 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 Canadian Posture and Seating Centre, Inc. devices

Submission Details

510(k) Number K894767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1989
Decision Date January 17, 1990
Days to Decision 175 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INN Chair, Adjustable, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3100
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.