Cleared Traditional

K926314 - HYDRA FITNESS MODEL 311 TOTAL POWER

K926314 is an FDA 510(k) clearance for HYDRA FITNESS MODEL 311 TOTAL POWER, manufactured by Henley Intl.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K926314 · Henley Intl. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
458d
Days
Class 2
Risk

K926314 is an FDA 510(k) clearance for the HYDRA FITNESS MODEL 311 TOTAL POWER. 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 18, 1994 after a review of 458 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

FDA 510(k) Submission Details - K926314

510(k) Number K926314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1992
Decision Date March 18, 1994
Days to Decision 458 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
343d slower than avg
Panel avg: 115d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K926314.
STAIR CLIMBER
K926278 · Henley Intl. · May 1994
UPPER BODY EXERCISER
K926279 · Henley Intl. · May 1994
EXERCISE BICYCLE
K926287 · Henley Intl. · Mar 1994
CABLE COLUMN WEIGHT SYSTEM MODEL #940-200
K922602 · Biodan Medical Systems, Ltd. · Jun 1992
TOTAL WORK INTEGRATOR, MODEL #940-110
K922603 · Biodan Medical Systems, Ltd. · Jun 1992
MULTI JOINT WEIGHT SYSTEM MODEL #940-100
K922606 · Biodan Medical Systems, Ltd. · Jun 1992