510(k) Report

510(k) · Cleared

Cleared

Winco Model Power Series Lift Chair

K080533510(k) TraditionalCleared Aug 11, 2008167-day reviewClass II21 CFR 890.3110

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

Winco, Inc. · INO Chair, Positioning, Electric

Cleared on Aug 11, 2008 after a 167-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided
Aug 11, 2008
Review
167 days
Class
Class II
Product code
INO
Recalls
None
Predicates
1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K080533Source: 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK707950Pride Mobility Model C5 Lift Chairs
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…ries Lit Chair '" K080533 Predicate Device Pride Mobility Model C5 Lift Chairs (K707950) Intended Use The intended use of the Winco Inc. Model Power Series Lift Chair is…

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 INO devices

INO Chair, Positioning, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · INO

1in 2014

2007: 22008: 22009: 42010: 12011: 12013: 12014: 1
2007high 4 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INO

126in 2009

2009: 126 days median
2007high 126 (2009)2026

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

Recalls per year · INO

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INO

29in 2025

2007: 12008: 52009: 62010: 72011: 202012: 152013: 242014: 162015: 232016: 352017: 382018: 382019: 372020: 412021: 492022: 292023: 292024: 202025: 29
2007high 49 (2021) · low 1 (2007)2025

MAUDE reports naming product code INO, 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
20072—01
20082—05
2009412606
20101—07
20111—020
20120—015
20131—024
20141—016
20150—023
20160—035
20170—038
20180—038
20190—037
20200—041
20210—049
20220—129
20230—029
20240—020
20250—029
20260—0—

What is it indicated for?

To assist persons who have difficulty rising from a seated position to a standing position.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K080533: Winco Model Power Series Lift Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080533

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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