Cleared Traditional

2K-QDA MOTION/GAIT ANALYSIS SYSTEM (K880631) - FDA 510(k) Clearance

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

K880631 · Human Performance Technologies, Inc. · Physical Medicine device
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Apr 1988
Decision
65d
Days
Class 2
Risk

K880631 is an FDA 510(k) clearance for the 2K-QDA MOTION/GAIT ANALYSIS SYSTEM. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Human Performance Technologies, Inc. (East Setauket, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Human Performance Technologies, Inc. devices

Submission Details

510(k) Number K880631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1988
Decision Date April 21, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXJ Interactive Rehabilitation Exercise Devices
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 - LXJ Interactive Rehabilitation Exercise Devices

All 26
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K880631.
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