510(k) Report

510(k) · Cleared

Cleared

UPnRIDE

K182257510(k) TraditionalCleared Sep 12, 2019387-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

Upnride Robotics, Ltd. · IPL Wheelchair, Standup

Cleared on Sep 12, 2019 as substantially equivalent to K051387 (Levo AG, 2005) after a 387-day review. Its family tree reaches back 2 generations to 1997.

Decided
Sep 12, 2019
Review
387 days
Class
Class II
Product code
IPL
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K963817 (1997). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestorReference device: K172384 · Quickie (r) Q700-UP M · Sunrise Medical (Us), LLC · 2018K963817 · Levo Mobil LCM · Levo USA · 1997K051387 · Levo Comfort II · Levo AG · 2005199520002005201020152020
Other ancestors, by generation 2 generations back: 1 other ancestor K051387 · Levo Comfort II · Levo AG · 2005K963817 · Levo Mobil LCM · Levo USA · 19970
  1. Root · 2 generations backK963817 Levo Mobil LCMLevo USA · 1997
  2. 1 generation backK051387 Levo Comfort IILevo AG · 2005
  3. This deviceK182257 UPnRIDEUpnride Robotics, Ltd. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K963817Levo Mobil LCMLevo USA1997—
−1K051387Levo Comfort IILevo AG2005—
0 (this device)K182257UPnRIDEUpnride Robotics, Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K182257, 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
*K051387Levo Comfort II
Summary page 6
…predicate and reference devices is Device Name 510k No Date of Clearance Predicate Levo comfort II K051387 June 10, 2005 Reference Quickie® Q700-UP M K172384 January 16, 2018 claimed: Comparison with Predicat…
Levo AG2005—
†K172384Quickie (r) Q700-UP MSunrise Medical (Us), LLC2018—

Also cleared against K051387: 3 other devices →

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 14.3 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K051387.

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 UPnRIDE™ stand-up power wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. The product changes people's position from Sitting to Standing and Standing to Sitting but also any position in between. The product provides indoor and outdoor mobility.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K182257: UPnRIDE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182257

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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