Cleared Traditional

K954162 - ERGOSEAT SYSTEM

K954162 is an FDA 510(k) clearance for ERGOSEAT SYSTEM, manufactured by Ergo-Air, Inc.. The device is a Class 2 Physical Medicine device with product code MOC cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K954162 · Ergo-Air, Inc. · Physical Medicine device
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Oct 1995
Decision
55d
Days
Class 2
Risk

K954162 is an FDA 510(k) clearance for the ERGOSEAT SYSTEM. Classified as Cushion, Flotation, Therapeutic (product code MOC), Class II - Special Controls.

Submitted by Ergo-Air, Inc. (Marblehead, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - 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 Ergo-Air, Inc. devices

FDA 510(k) Submission Details - K954162

510(k) Number K954162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date October 30, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOC Device Classification - Class 2, Special Controls

Product Code MOC Cushion, Flotation, Therapeutic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
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.