Cleared Traditional

K894017 - POWER PODIATRY CHAIR/TABLE #414, #416 & #417 (FDA 510(k) Clearance)

Class I Physical Medicine device.

K894017 · Midmark Corp. · Physical Medicine device
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Jul 1989
Decision
42d
Days
Class 1
Risk

K894017 is an FDA 510(k) clearance for the POWER PODIATRY CHAIR/TABLE #414, #416 & #417. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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 Midmark Corp. devices

Submission Details

510(k) Number K894017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1989
Decision Date July 14, 1989
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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.