Cleared Traditional

K900307 - KARE CHAIR I

K900307 is an FDA 510(k) clearance for KARE CHAIR I, manufactured by Kare Chair Industries, Inc.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K900307 · Kare Chair Industries, Inc. · Physical Medicine device
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Feb 1990
Decision
25d
Days
Class 2
Risk

K900307 is an FDA 510(k) clearance for the KARE CHAIR I. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Kare Chair Industries, Inc. (Findley, US). The FDA issued a Cleared decision on February 15, 1990 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kare Chair Industries, Inc. devices

FDA 510(k) Submission Details - K900307

510(k) Number K900307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1990
Decision Date February 15, 1990
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
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.