Cleared Traditional

K931832 - THE HILL ADJUSTABLE HA90

K931832 is an FDA 510(k) clearance for THE HILL ADJUSTABLE HA90, 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 81-day FDA review.

Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
81d
Days
Class 1
Risk

K931832 is an FDA 510(k) clearance for the THE HILL ADJUSTABLE HA90. 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 June 29, 1993 after a review of 81 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 Hill Laboratories Co. devices

FDA 510(k) Submission Details - K931832

510(k) Number K931832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1993
Decision Date June 29, 1993
Days to Decision 81 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
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 21
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K931832.
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MODELS 642 & 643 TILT EXAM/TREATMENT TABLE
K930802 · Tri W-G, Inc. · Mar 1993
MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE
K925594 · Tri W-G, Inc. · Feb 1993
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K923325 · Tri W-G, Inc. · Jul 1992