510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series

K973673510(k) TraditionalCleared Nov 20, 199755-day reviewClass I21 CFR 890.3850Recalls 4

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

Sunrise Medical, Inc. · IOR Wheelchair, Mechanical

Cleared on Nov 20, 1997 after a 55-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 4 times.

Decided
Nov 20, 1997
Review
55 days
Class
Class I
Product code
IOR
Recalls
4
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2011: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973673 Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series…Sunrise Medical, Inc. · 1997
  2. Descendant · cites it directly · 0 of its ownK182840 Element Pediatric WheelchairLeggero, LLC · 2019
  3. Descendant · cites it directly · 0 of its ownK103073 Super Chair for Kids by OrionFuture Mobility Healthcare, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K182840Element Pediatric WheelchairLeggero, LLC · 2019 · cites it directly0descendants
  • K103073Super Chair for Kids by OrionFuture Mobility Healthcare, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973673Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie…Sunrise Medical, Inc.1997—
+1K182840Element Pediatric WheelchairLeggero, LLC2019—
+1K103073Super Chair for Kids by OrionFuture Mobility Healthcare, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201910
FIG. 1 — Lineage of K973673, 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 IOR? 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 IOR device

  1. #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*—Sunrise Medical’s Zippie, Quickie, and Breezy Series Wheelchairs
Named without a submission number
—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182840Element Pediatric WheelchairLeggero, LLC20190
K103073Super Chair for Kids by OrionFuture Mobility Healthcare, Inc.20110

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 19, 2014Class IIZ-1019-2015Device DesignThere is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
Jun 26, 2012Class IIZ-2113-2012Labeling designReports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.
Jan 13, 2012Not classifiedZ-1103-2012Employee errorOne Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.
Feb 2, 2009Not classifiedZ-0831-2011Process change controlThe stabilizer bar was inadvertently omitted during the manufacturing process.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K182840 (Leggero, LLC, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IOR devices

IOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IOR

17so far in 2026, the most since 2007

2007: 52008: 132009: 42010: 122011: 62012: 112013: 72014: 72015: 32016: 102017: 72018: 32019: 62020: 22021: 22022: 42023: 92024: 42025: 72026 (partial year): 17
2007high 17 (2026) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOR

91in 2025

2007: 38 days median2008: 32 days median2009: 43 days median2010: 81 days median2011: 58 days median2012: 176 days median2013: 233 days median2014: 211 days median2015: 104 days median2016: 135 days median2017: 209 days median2018: 203 days median2019: 160 days median2022: 150 days median2023: 61 days median2024: 65 days median2025: 91 days median2026 (partial year): 103 days median
2007high 233 (2013) · low 32 (2008)2026

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

Recalls per year · IOR

1in 2021

2007: 12008: 32009: 22011: 62012: 32013: 32014: 32016: 12021: 1
2007high 6 (2011) · low 0 (2010)2026

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

Adverse event reports per year · IOR

135in 2025

2007: 362008: 622009: 542010: 692011: 2322012: 1,2382013: 4,6742014: 5,0822015: 4,4722016: 1,8602017: 492018: 582019: 532020: 432021: 592022: 372023: 1652024: 1382025: 135
2007high 5,082 (2014) · low 36 (2007)2025

MAUDE reports naming product code IOR, 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
2007538136
20081332362
2009443254
20101281069
20116586232
20121117631,238
2013723334,674
2014721135,082
2015310404,472
20161013511,860
20177209049
20183203058
20196160053
20202—043
20212—159
20224150037
20239610165
20244650138
20257910135
2026171030—

What is it indicated for?

Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as:

Arthritis Tetraplegic Multiple Sclerosis

Amputee Quadriplegic Polio

Paraplegic Spina Bifida Geriatric conditions

Cerebral Palsy Head Injury or Trauma and other Immobilizing or debilitating condition

Hemiplegic Muscular Dystrophy

Claim being added:

A wheelchair with the Bus Transport option, may be used for motor vehicle transportation, with the use of Wheelchair tiedown and occupant restraint systems (WTORS) that meet the requirements of SAE J2249.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K973673: Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973673

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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