510(k) Report

510(k) · Cleared

Cleared

ATTO Mobility Scooter

K160909510(k) TraditionalCleared Oct 4, 2016186-day reviewClass II21 CFR 890.3800

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

Moving Life, Ltd. · INI Vehicle, Motorized 3-Wheeled

Cleared on Oct 4, 2016 as substantially equivalent to K110165 (Freerider Luggie Scooters, Inc., 2011) after a 186-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.

Decided
Oct 4, 2016
Review
186 days
Class
Class II
Product code
INI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K110165 (2011). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant clearedK110165 · Freerider Model Luggie Model 168-4IT · Freerider Luggie Scooters, Inc. · 20112010201520202025
Descendants, by generation 1 generation forward: 1 descendant K110165 · Freerider Model Luggie Model 168-4IT · Freerider Luggie Scooters, Inc. · 20110
  1. Root · 1 generation backK110165 Freerider Model Luggie Model 168-4ITFreerider Luggie Scooters, Inc. · 2011
  2. This deviceK160909 ATTO Mobility ScooterMoving Life, Ltd. · 2016
  3. Descendant · cites it directly · 0 of its ownK222703 ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO…Moving Life, Ltd. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K222703ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter…Moving Life, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K110165Freerider Model Luggie Model 168-4ITFreerider Luggie Scooters, Inc.2011—
0 (this device)K160909ATTO Mobility ScooterMoving Life, Ltd.2016—
+1K222703ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility…Moving Life, Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K160909, 2011–2023Source: 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 INI? 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 INI device

  1. #1 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 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? (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
*K110165Freerider Model Luggie Model 168-4IT
Summary page 4
…vehicle; INI; 890.3800 C. Legally Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Manufacturer K110165 INI Luggie Freerider Corporation D. Device Description ATTO Mob…
Freerider Luggie Scooters, Inc.2011—

Also cleared against K110165: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222703ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter…Moving Life, Ltd.20230

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 no recall.
  • Of its descendants, K222703 (Moving Life, Ltd., 2023) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K110165.

How does its category compare?

All INI devices

INI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · INI

21so far in 2026, the most since 2007

2007: 182008: 72009: 122010: 52011: 52012: 12013: 22014: 12015: 92016: 12017: 52018: 32019: 42020: 12021: 52022: 62023: 92024: 82025: 152026 (partial year): 21
2007high 21 (2026) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INI

111in 2025

2007: 29 days median2008: 28 days median2009: 41 days median2010: 46 days median2011: 130 days median2015: 202 days median2017: 191 days median2018: 266 days median2019: 298 days median2021: 575 days median2022: 159 days median2023: 123 days median2024: 137 days median2025: 111 days median2026 (partial year): 108 days median
2007high 575 (2021) · low 28 (2008)2026

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

Recalls per year · INI

1in 2013

2007: 22010: 32011: 32013: 1
2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · INI

26in 2025

2007: 642008: 292009: 252010: 562011: 702012: 1722013: 4542014: 5672015: 1512016: 762017: 452018: 512019: 252020: 262021: 412022: 412023: 322024: 312025: 26
2007high 567 (2014) · low 25 (2009)2025

MAUDE reports naming product code INI, 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
20071829264
2008728029
20091241025
2010546356
20115130370
20121—0172
20132—1454
20141—0567
201592020151
20161—076
20175191045
20183266051
20194298025
20201—026
20215575041
20226159041
20239123032
20248137031
202515111026
2026211080—

What is it indicated for?

ATTO Mobility Scooter is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K160909: ATTO Mobility Scooter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160909

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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