510(k) · Cleared

Cleared

Freerider, Model FR510-F

K971387510(k) TraditionalCleared Jul 23, 1997100-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

Freerider USA, Inc. · INI Vehicle, Motorized 3-Wheeled

Cleared on Jul 23, 1997 as substantially equivalent to K920654 (Pride Health Care, Inc., 1992) after a 100-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Jul 23, 1997
Review: 100 days
Class: Class II
Product code: INI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K920654 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK920654 Shoprider - TE889Pride Health Care, Inc. · 1992
This deviceK971387 Freerider, Model FR510-FFreerider USA, Inc. · 1997
Descendant · cites it directly · 0 of its ownK133187 FREERIDER FR1, models FR1-13, FR1-15, FR1-17Freerider Corp · 2015

Most influential descendants

Showing 1 of 1 · See all

K133187FREERIDER FR1, models FR1-13, FR1-15, FR1-17Freerider Corp · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920654	Shoprider - TE889	Pride Health Care, Inc.	1992	—
0 (this device)	K971387	Freerider, Model FR510-F	Freerider USA, Inc.	1997	—
+1	K133187	FREERIDER FR1, models FR1-13, FR1-15, FR1-17	Freerider Corp	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K971387, 1992–2015Source: 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
*	K920654	Shoprider - TE889 Summary page 1 …890.3800. Legally marketed device for substantial equivalence comparison: Shoprider™-TE889 submitted by Pride Health Care, Inc. and cleared for marketing under 510(k) *K920654. Description of the device: The Freerider Model FR510-F is a motorized four-wheeled scooter which is battery operated. It consis…	Pride Health Care, Inc.	1992	—

Also cleared against K920654: 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.

Number	Device	Applicant	Decided	Descendants
K133187	FREERIDER FR1, models FR1-13, FR1-15, FR1-17	Freerider Corp	2015	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, K133187 (Freerider Corp, 2015) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K920654.

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 Freerider Model FR510-F is a motorized scooter which provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

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

https://510kreport.com/device/K971387 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971387: Freerider, Model FR510-F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971387

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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