Cleared Traditional

THE HILL ADJUSTABLE HA90E (K942026) - FDA 510(k) Clearance

Class I Physical Medicine device.

K942026 · Hill Laboratories Co. · Physical Medicine device
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Feb 1995
Decision
297d
Days
Class 1
Risk

K942026 is an FDA 510(k) clearance for the THE HILL ADJUSTABLE HA90E. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Hill Laboratories Co. (Malvern, US). The FDA issued a Cleared decision on February 17, 1995 after a review of 297 days - an extended review 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: 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 Hill Laboratories Co. devices

Submission Details

510(k) Number K942026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1994
Decision Date February 17, 1995
Days to Decision 297 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
182d slower than avg
Panel avg: 115d · This submission: 297d
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.