Cleared Traditional

THE HILL HI-LO TABLE (K934754) - FDA 510(k) Clearance

Class I Physical Medicine device.

K934754 · Hill Laboratories Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
501d
Days
Class 1
Risk

K934754 is an FDA 510(k) clearance for the THE HILL HI-LO TABLE. 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 501 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Hill Laboratories Co. devices

Submission Details

510(k) Number K934754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date February 17, 1995
Days to Decision 501 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
386d slower than avg
Panel avg: 115d · This submission: 501d
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.