510(k) Report

510(k) · Cleared

Cleared

Merits Model E Series Lift Chairs

K060212510(k) AbbreviatedCleared Mar 7, 200639-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

Merits Health Products Co., Ltd. · INO Chair, Positioning, Electric

Cleared on Mar 7, 2006 as substantially equivalent to K880800 (Golden Technologies, Inc., 1988) after a 39-day review. Its family tree reaches back 1 generation to 1988.

Decided
Mar 7, 2006
Review
39 days
Class
Class II
Product code
INO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K880800 (1988). No later device cites it as a predicate yet.

K880800 · Golden Power Lift Chair · Golden Technologies, Inc. · 1988 · recalled19851990199520002005
  1. Root · 1 generation backK880800 Golden Power Lift ChairGolden Technologies, Inc. · 1988 · Recalled
  2. This deviceK060212 Merits Model E Series Lift ChairsMerits Health Products Co., Ltd. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K880800Golden Power Lift ChairGolden Technologies, Inc.19881
0 (this device)K060212Merits Model E Series Lift ChairsMerits Health Products Co., Ltd.2006—
FIG. 1 — Lineage of K060212, 1988–2006Source: 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 INO? 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
*K880800Golden Power Lift Chair
Summary page 1
…vices The Merits Health Products Model E Series Lift Chairs are substantially equivalent to the GOLDEN POWER LIFT CHAIR Model PR355M (K880800). 9.5 Device Description The Merits Pioneer Model E Series Lift Chair operates using standard AC…
Golden Technologies, Inc.19881

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?

  • Its one ancestor has a 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.

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?

The Merits Model E Series Lift Chairs are intended to assist elderly and/or physically challenged 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. “K060212: Merits Model E Series Lift Chairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060212

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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