Cleared Traditional

COMPUTERIZED TESTING AND EXERCISE SYSTEMS (K926313) - FDA 510(k) Clearance

Class I Physical Medicine device.

K926313 · Henley Intl. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
416d
Days
Class 1
Risk

K926313 is an FDA 510(k) clearance for the COMPUTERIZED TESTING AND EXERCISE SYSTEMS. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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 Henley Intl. devices

Submission Details

510(k) Number K926313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1992
Decision Date February 04, 1994
Days to Decision 416 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
301d slower than avg
Panel avg: 115d · This submission: 416d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.