510(k) Report

510(k) · Cleared

Cleared

Frontier Series Power Wheelchairs

K213090510(k) TraditionalCleared Nov 19, 202156-day reviewClass II21 CFR 890.3860

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

Magic Mobility · ITI Wheelchair, Powered

Cleared on Nov 19, 2021 as substantially equivalent to K030783 (Vestil Manufacturing Corp., 2003) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 1990.

Decided
Nov 19, 2021
Review
56 days
Class
Class II
Product code
ITI
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K900565 (1990). 9 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 5 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
  2. 4 generations backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
  3. 3 generations backK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
  4. 2 generations backK012909 Xterra GT Power WheelchairInvacare Corp. · 2001
  5. 1 generation backK030783 Frontier Model X5Vestil Manufacturing Corp. · 2003
  6. This deviceK213090 Frontier Series Power WheelchairsMagic Mobility · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K900565Invacare Power 9000 Series WheelchairInvacare Corp.1990—
−4K982064Action Storm Ranger II, Action Storm Power 9000Invacare Corp.1998—
−3K991168Arrow FWD Power WheelchairInvacare Corp.19992
−2K012909Xterra GT Power WheelchairInvacare Corp.2001—
−1K030783Frontier Model X5Vestil Manufacturing Corp.2003—
0 (this device)K213090Frontier Series Power WheelchairsMagic Mobility2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200610
200810
201410
FIG. 1 — Lineage of K213090, 1990–2021Source: 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 ITI? 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 ITI device

  1. #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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
*K030783Frontier Model X5
Summary page 4
…wer Wheelchairs are substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Predicate Relationship K030783 Frontier Power Wheelchair/ Innovation In Motion Primary Predicate…
Vestil Manufacturing Corp.2003—
*K142457Quickie, Zippie
Summary page 4
…Frontier Power Wheelchair/ Innovation In Motion Primary Predicate Device K142457 Quickie® and Zippie® Powered Wheelchairs / Secondary Predicate Sunrise Medical (US) LLC…
Sunrise Medical (Us), LLC20141
†K172384Quickie (r) Q700-UP MSunrise Medical (Us), LLC2018—

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 31 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • 2 of the 9 ancestors have a recall of any class.

How does its category compare?

All ITI devices

ITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · ITI

29in 2025

2007: 182008: 92009: 72010: 62011: 42012: 62013: 52014: 52015: 102016: 62017: 42018: 42019: 32020: 62021: 132022: 162023: 82024: 382025: 292026 (partial year): 36
2007high 38 (2024) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITI

90in 2025

2007: 42 days median2008: 49 days median2009: 63 days median2010: 46 days median2011: 101 days median2012: 155 days median2013: 177 days median2014: 213 days median2015: 174 days median2016: 173 days median2017: 159 days median2018: 117 days median2019: 244 days median2020: 278 days median2021: 209 days median2022: 96 days median2023: 128 days median2024: 125 days median2025: 90 days median2026 (partial year): 108 days median
2007high 278 (2020) · low 42 (2007)2026

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

Recalls per year · ITI

13so far in 2026, the most since 2007

2007: 32008: 32009: 12010: 22012: 12016: 12017: 22021: 32024: 12025: 3, 2 Class I2026 (partial year): 13
2007high 13 (2026) · low 0 (2011)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · ITI

647in 2025

2007: 1232008: 1332009: 1832010: 1572011: 5252012: 2,9192013: 8,7412014: 7,2822015: 4,6852016: 1,5752017: 3012018: 2732019: 2642020: 2052021: 1662022: 1352023: 2232024: 1462025: 647
2007high 8,741 (2013) · low 123 (2007)2025

MAUDE reports naming product code ITI, 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
200718423123
20089493133
20097631183
20106462157
201141010525
2012615512,919
2013517708,741
2014521307,282
20151017404,685
2016617311,575
201741592301
201841170273
201932440264
202062780205
2021132093166
202216960135
202381280223
2024381251146
202529903 (2)647
20263610813—

What is it indicated for?

The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K213090: Frontier Series Power Wheelchairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213090

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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