Cleared Traditional

K926287 - EXERCISE BICYCLE

K926287 is the FDA 510(k) clearance for EXERCISE BICYCLE by Henley Intl.. It is a Class 2 Physical Medicine device (product code ISD) cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K926287 · Henley Intl. · Physical Medicine device
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Mar 1994
Decision
463d
Days
Class 2
Risk

K926287 is an FDA 510(k) clearance for the EXERCISE BICYCLE. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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 K926287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date March 22, 1994
Days to Decision 463 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
348d slower than avg
Panel avg: 115d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 - ISD Exerciser, Measuring

All 14
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K926287.
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STAIR CLIMBER
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UPPER BODY EXERCISER
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HYDRA FITNESS MODEL 311 TOTAL POWER
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MONARK ERGOMETERS
K912227 · Quinton, Inc. · Aug 1991
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K880032 · Medex, Inc. · Feb 1988