Cleared Traditional

K942026 - THE HILL ADJUSTABLE HA90E

K942026 is an FDA 510(k) clearance for THE HILL ADJUSTABLE HA90E, manufactured by Hill Laboratories Co.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K942026 · Hill Laboratories Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K942026

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 116d · This submission: 297d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - INQ Table, Powered

All 48
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K942026.
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K950362 · Cardon Rehabilitation Products, Inc. · Feb 1995