510(k) Report

510(k) · Cleared

Cleared

Uincare Home

K172882510(k) TraditionalCleared May 10, 2018231-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

Uincare Corp. · LXJ Interactive Rehabilitation Exercise Devices

Cleared on May 10, 2018 as substantially equivalent to K151446 (Recovr,Inc, 2015) after a 231-day review. Its family tree reaches back 5 generations to 1989.

Decided
May 10, 2018
Review
231 days
Class
Class II
Product code
LXJ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K890076 (1989). 6 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 5 generations backK890076 OrthotrakMotion Analysis Corp. · 1989
  2. 4 generations backK982425 Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998
  3. 3 generations backK030714 Peak MotusPeak Performance Technologies, Inc. · 2003
  4. 2 generations backK130847 Jintronix Rehabilitation System (JRS)Jintronix, Inc. · 2014
  5. 1 generation backK151446 Recovr Rehabilitation SystemRecovr,Inc · 2015
  6. This deviceK172882 Uincare HomeUincare Corp. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K890076OrthotrakMotion Analysis Corp.1989—
−4K982425Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering1998—
−3K030714Peak MotusPeak Performance Technologies, Inc.2003—
−2K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc.2014—
−1K151446Recovr Rehabilitation SystemRecovr,Inc2015—
0 (this device)K172882Uincare HomeUincare Corp.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K172882, 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.

Planning a device in LXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • 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
*K151446Recovr Rehabilitation System
Summary page 5
…his submission are shown as follow; Contents Primary Predicate Reference Predicate 510(k) Number K151446 K150462 Device Name Recovr Rehabilitation System Vera™ Applican…
Recovr,Inc2015—
†K150462VeraReflexion Health, Inc.2015—

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.

What does this lineage say?

  • The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
  • None of the 6 ancestors has a 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. 2018, 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—

What is it indicated for?

The UINCARE software system used with the Microsoft Kinect is intended to be used to support the physical

rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper

extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible

patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the

medical professional is required prior to use.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K172882: Uincare Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172882

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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