Cleared Traditional

K781559 - LIFTING CHAIR & LIFTING LAVATORY SEAT

K781559 is an FDA 510(k) clearance for LIFTING CHAIR & LIFTING LAVATORY SEAT, manufactured by Motor Riser Chairs , Ltd.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K781559 · Motor Riser Chairs , Ltd. · Physical Medicine device
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Oct 1978
Decision
22d
Days
Class 2
Risk

K781559 is an FDA 510(k) clearance for the LIFTING CHAIR & LIFTING LAVATORY SEAT. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Motor Riser Chairs , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 22 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.

FDA 510(k) Submission Details - K781559

510(k) Number K781559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1978
Decision Date October 03, 1978
Days to Decision 22 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
94d faster than avg
Panel avg: 116d · This submission: 22d
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.

K781559 · LIFTING CHAIR & LIFTING LAVATORY SEAT
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