Cleared Traditional

K923804 - PORTABLE LIFT SEAT

K923804 is an FDA 510(k) clearance for PORTABLE LIFT SEAT, manufactured by Frank H. Speckhart, P.E.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K923804 · Frank H. Speckhart, P.E. · Physical Medicine device
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Feb 1993
Decision
198d
Days
Class 2
Risk

K923804 is an FDA 510(k) clearance for the PORTABLE LIFT SEAT. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Frank H. Speckhart, P.E. (Knoxville, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 198 days - an extended review 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: 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 Frank H. Speckhart, P.E. devices

FDA 510(k) Submission Details - K923804

510(k) Number K923804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1992
Decision Date February 12, 1993
Days to Decision 198 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
83d slower than avg
Panel avg: 115d · This submission: 198d
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.