Cleared Traditional

THE HILL ADJUSTABLE AIR-FLEX MODEL (K932810) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932810 · Hill Laboratories Co. · Physical Medicine device
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Feb 1995
Decision
618d
Days
Class 2
Risk

K932810 is an FDA 510(k) clearance for the THE HILL ADJUSTABLE AIR-FLEX MODEL. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Hill Laboratories Co. (Malvern, US). The FDA issued a Cleared decision on February 17, 1995 after a review of 618 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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 K932810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date February 17, 1995
Days to Decision 618 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
503d slower than avg
Panel avg: 115d · This submission: 618d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 65
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