510(k) Report

510(k) · Cleared

Cleared

Modular Power Standing System

K191376510(k) TraditionalCleared Aug 13, 201982-day reviewClass II21 CFR 890.3900

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

Motion Concepts · IPL Wheelchair, Standup

Cleared on Aug 13, 2019 as substantially equivalent to K083017 (Levo AG, 2008) after an 82-day review. Its family tree reaches back 5 generations to 1997.

Decided
Aug 13, 2019
Review
82 days
Class
Class II
Product code
IPL
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K960951 (1997). 10 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 5 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
  2. 4 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
  3. 3 generations backK041219 ElectroPermobil AB · 2004 · Recalled
  4. 2 generations backK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
  5. 1 generation backK083017 LEVO C3Levo AG · 2008
  6. This deviceK191376 Modular Power Standing SystemMotion Concepts · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K960951Permobil Chairman L/CS 8Permobil AB1997—
−4K991658Permobil Powered Wheelchair 1280Permobil AB19995
−3K041219ElectroPermobil AB20044
−2K071650C350 Powered WheelchairPermobil AB20073
−1K083017LEVO C3Levo AG2008—
0 (this device)K191376Modular Power Standing SystemMotion Concepts2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200320
200510
FIG. 1 — Lineage of K191376, 1997–2019Source: 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 IPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IPL device

  1. #1 K203761 ParaMotionscore 3.3 · 3 generations · no Class I recall
  2. #2 Held for the reportin 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
*K083017LEVO C3
Summary page 4
…s II III. PREDICATE DEVICE Predicate Device: Levo C3 Power Wheelchair K083017 Product Code IPL…
Levo AG2008—
†K150574Modular Power Positioning SystemMotion Concepts2015—

Also cleared against K083017: 1 other device →

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 22 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
  • 4 of the 10 ancestors have a recall of any class.
  • 1 other device also cites its predicate K083017.

How does its category compare?

All IPL devices

IPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · IPL

1in 2025

2007: 32008: 12009: 12010: 22013: 12015: 12018: 22019: 32020: 22022: 22025: 1
2007high 3 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPL

105in 2019

2007: 63 days median2019: 105 days median
2007high 105 (2019) · low 63 (2007)2026

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

Recalls per year · IPL

No recall names IPL since 2007.

Adverse event reports per year · IPL

5in 2025

2008: 12010: 12013: 32014: 12015: 32018: 12019: 12021: 42022: 32023: 92024: 62025: 5
2007high 9 (2023) · low 0 (2007)2025

MAUDE reports naming product code IPL, 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
200736300
20081—01
20091—00
20102—01
20110—00
20120—00
20131—03
20140—01
20151—03
20160—00
20170—00
20182—01
2019310501
20202—00
20210—04
20222—03
20230—09
20240—06
20251—05
20260—0—

What is it indicated for?

The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing, standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K191376: Modular Power Standing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191376

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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