510(k) Report

510(k) · Cleared

Cleared

Coda CX1 Motion Analysis System

K033514510(k) TraditionalCleared Jan 6, 200461-day reviewClass II21 CFR 890.5360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Charnwood Dynamics, Ltd. · LXJ Interactive Rehabilitation Exercise Devices

Cleared on Jan 6, 2004 as substantially equivalent to K982425 (Pinsco Inc. Dba B & L Engineering, 1998) after a 61-day review. Its family tree reaches back 2 generations to 1989. 10 later devices descend from it.

Decided
Jan 6, 2004
Review
61 days
Class
Class II
Product code
LXJ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K890076 (1989). 10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2009: 1 descendant cleared2017: 1 descendant cleared2015: 3 descendants cleared2016: 1 descendant cleared2018: 2 descendants clearedK890076 · Orthotrak · Motion Analysis Corp. · 1989K982425 · Coda MPX30 Motion Analysis System · Pinsco Inc. Dba B & L Engineering · 19981990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K982425 · Coda MPX30 Motion Analysis System · Pinsco Inc. Dba B & L Engineering · 1998K890076 · Orthotrak · Motion Analysis Corp. · 19890
  1. Root · 2 generations backK890076 OrthotrakMotion Analysis Corp. · 1989
  2. 1 generation backK982425 Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998
  3. This deviceK033514 Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd. · 2004
  4. Descendant · cites it directly · 6 of its ownK130847 Jintronix Rehabilitation System (JRS)Jintronix, Inc. · 2014
  5. Descendant · 2 generations on · 1 of its ownK151446 Recovr Rehabilitation SystemRecovr,Inc · 2015
  6. Descendant · cites it directly · 1 of its ownK131660 Smart (Smart-D, Smart-DX)Bts S.P.A. · 2014
  7. Descendant · 2 generations on · 0 of its ownK171547 Qualisys Clinical SystemQualisys AB · 2018
  8. Descendant · 3 generations on · 0 of its ownK172882 Uincare HomeUincare Corp. · 2018

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 12014: 22015: 32016: 12017: 12018: 2
2009high 3 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all
  • K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc. · 2014 · cites it directly6descendants
  • K151446Recovr Rehabilitation SystemRecovr,Inc · 2015 · 2 generations on1descendant
  • K131660Smart (Smart-D, Smart-DX)Bts S.P.A. · 2014 · cites it directly1descendant
  • K171547Qualisys Clinical SystemQualisys AB · 2018 · 2 generations on0descendants
  • K172882Uincare HomeUincare Corp. · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K890076OrthotrakMotion Analysis Corp.1989—
−1K982425Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering1998—
0 (this device)K033514Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd.2004—
+1K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc.2014—
+2K151446Recovr Rehabilitation SystemRecovr,Inc2015—
+1K131660Smart (Smart-D, Smart-DX)Bts S.P.A.2014—
+2K171547Qualisys Clinical SystemQualisys AB2018—
+3K172882Uincare HomeUincare Corp.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201420
201530
201610
201710
201820
FIG. 1 — Lineage of K033514, 1989–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K982425Coda MPX30 Motion Analysis System
Summary page 1
…Codamotion System 7. Classification Name: System / Optical Position / Movement Recording 8. Identification of Predicate Device(s): CODA mpx30 (K982425) 9. Device Description: Coda cxl Is an opticaVelectronic system which measures and analyses the 3D position a…
Pinsco Inc. Dba B & L Engineering1998—

Also cleared against K982425: 1 other device →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc.20146
K131660Smart (Smart-D, Smart-DX)Bts S.P.A.20141
K091000KneekgEmovi20090

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K130847 (Jintronix, Inc., 2014) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K982425.

How does its category compare?

All LXJ devices

LXJ Interactive Rehabilitation Exercise Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXJ

3in 2019

2009: 12014: 22015: 32016: 12017: 22018: 32019: 3
2007high 3 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXJ

224in 2019

2015: 182 days median2018: 231 days median2019: 224 days median
2007high 231 (2018) · low 182 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LXJ

No recall names LXJ since 2007.

Adverse event reports per year · LXJ

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code LXJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20142—00
2015318200
20161—00
20172—00
2018323101
2019322400
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Coda cx I Motion Analysis System has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K033514: Coda CX1 Motion Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033514

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026