Cleared Traditional

K033514 - CODA CX1 MOTION ANALYSIS SYSTEM

K033514 is an FDA 510(k) clearance for CODA CX1 MOTION ANALYSIS SYSTEM, manufactured by Charnwood Dynamics , Ltd.. The device is a Class 2 Physical Medicine device with product code LXJ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K033514 · Charnwood Dynamics , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
61d
Days
Class 2
Risk

K033514 is an FDA 510(k) clearance for the CODA CX1 MOTION ANALYSIS SYSTEM. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Charnwood Dynamics , Ltd. (Rothley, Leicestershire, GB). The FDA issued a Cleared decision on January 6, 2004 after a review of 61 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 Charnwood Dynamics , Ltd. devices

FDA 510(k) Submission Details - K033514

510(k) Number K033514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2003
Decision Date January 06, 2004
Days to Decision 61 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXJ Device Classification - Class 2, Special Controls

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 10
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