Cleared Traditional

K982425 - CODA MPX30 MOTION ANALYSIS SYSTEM

K982425 is an FDA 510(k) clearance for CODA MPX30 MOTION ANALYSIS SYSTEM, manufactured by Pinsco Inc. Dba B & L Engineering. The device is a Class 2 Physical Medicine device with product code LXJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K982425 · Pinsco Inc. Dba B & L Engineering · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
86d
Days
Class 2
Risk

K982425 is an FDA 510(k) clearance for the CODA MPX30 MOTION ANALYSIS SYSTEM. Classified as Interactive Rehabilitation Exercise Devices (product code LXJ), Class II - Special Controls.

Submitted by Pinsco Inc. Dba B & L Engineering (Tustin, US). The FDA issued a Cleared decision on October 7, 1998 after a review of 86 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.

FDA 510(k) Submission Details - K982425

510(k) Number K982425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date October 07, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 116d · This submission: 86d
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 26
Devices cleared under the same product code (LXJ) and FDA review panel - the closest regulatory comparables to K982425.
KNEEKG
K091000 · Emovi · Oct 2009
CODA CX1 MOTION ANALYSIS SYSTEM
K033514 · Charnwood Dynamics , Ltd. · Jan 2004
PEAK MOTUS
K030714 · Peak Performance Technologies, Inc. · May 2003
CERVICAL FUNCTION INDICATOR
K943430 · Whiplash Analysis, Inc. · Mar 1995
THE TRACKER
K923033 · Epm Information Systems, Inc. · Jun 1993
LIDO V-TAK
K924512 · Loredan Biomedical, Inc. · May 1993
K982425 · CODA MPX30 MOTION ANALYSIS SYSTEM
Download PDF FDA Summary Pinsco Inc. Dba B & L…