510(k) · Cleared

Cleared

GO GO Elite Traveller Plus 4 Wheel Scooter, Model SC54

K063389510(k) SpecialCleared Nov 17, 200615-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

Pride Mobility Products Corp. · INI Vehicle, Motorized 3-Wheeled

Cleared on Nov 17, 2006 as substantially equivalent to K930953 (Pride Health Care, Inc., 1994) after a 15-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Nov 17, 2006
Review: 15 days
Class: Class II
Product code: INI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K930953 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK930953 Celebrity SC440Pride Health Care, Inc. · 1994
This deviceK063389 GO GO Elite Traveller Plus 4 Wheel Scooter, Model SC54Pride Mobility Products Corp. · 2006
Descendant · cites it directly · 0 of its ownK110395 C.T.M. Mobility Scooter - Model HS 118C.T.M. Homecare Product, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all

K110395C.T.M. Mobility Scooter - Model HS 118C.T.M. Homecare Product, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930953	Celebrity SC440	Pride Health Care, Inc.	1994	—
0 (this device)	K063389	GO GO Elite Traveller Plus 4 Wheel Scooter, Model SC54	Pride Mobility Products Corp.	2006	—
+1	K110395	C.T.M. Mobility Scooter - Model HS 118	C.T.M. Homecare Product, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K063389, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K930953	Celebrity SC440 Summary page 1 …roduct Code: INI Comparison to Predicate Devices: The Go Go Elite Traveller Plus, Four Wheel Scooter is substantially equivalent to the Pride Mobility Sunrunner S;-440 (K930953) when comparing components, performance, maneuverability, stability, and structure. The performance characteristics and the posit…	Pride Health Care, Inc.	1994	—

Also cleared against K930953: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K110395	C.T.M. Mobility Scooter - Model HS 118	C.T.M. Homecare Product, Inc.	2011	0

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, K110395 (C.T.M. Homecare Product, Inc., 2011) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K930953.

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.

FDA decisions per year · INI

21so far in 2026, the most since 2007

2007high 21 (2026) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INI

111in 2025

2007high 575 (2021) · low 28 (2008)2026

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

Recalls per year · INI

1in 2013

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	29	2	64
2008	7	28	0	29
2009	12	41	0	25
2010	5	46	3	56
2011	5	130	3	70
2012	1	—	0	172
2013	2	—	1	454
2014	1	—	0	567
2015	9	202	0	151
2016	1	—	0	76
2017	5	191	0	45
2018	3	266	0	51
2019	4	298	0	25
2020	1	—	0	26
2021	5	575	0	41
2022	6	159	0	41
2023	9	123	0	32
2024	8	137	0	31
2025	15	111	0	26
2026	21	108	0	—

What is it indicated for?

The intended use of the Pride Mobility Products Corporation Go Go Elite Traveller Plus, Four Wheel Scooter, is to provide mobility to persons having limited walking capabilities, The compact design and ease of assembly and disassembly, also provides a mobility product that transports easily for travel usage.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063389 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063389: GO GO Elite Traveller Plus 4 Wheel Scooter, Model SC54.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063389

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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