510(k) Report

510(k) · Cleared

Cleared

Vera

K182333510(k) TraditionalCleared Apr 9, 2019224-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

Reflexion Health, Inc. · LXJ Interactive Rehabilitation Exercise Devices

Cleared on Apr 9, 2019 after a 224-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Apr 9, 2019
Review
224 days
Class
Class II
Product code
LXJ
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K182333Source: FDA 510(k) database · 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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.

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. 2019, this device’s year, is highlighted.

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—

More from Reflexion Health, Inc.

3 FDA decisions under this applicant name. See the company

  • K192474VERAReflexion Health, Inc. · 2019
  • K150462VeraReflexion Health, Inc. · 2015

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The LXJ category page

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  • K180880DARI HealthScientific Analytics, Inc. · 2019
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  • K173931MindMotion (TM) GOMindmaze SA · 2018
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https://510kreport.com/device/K182333 · printed Nov 5, 2026

Cite this page

510(k) Report. “K182333: Vera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182333

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