510(k) · Cleared
ClearedShoprider - TE889
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pride Health Care, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on Mar 12, 1992 after a 29-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 12, 1992
- Review
- 29 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK920654 Shoprider - TE889Pride Health Care, Inc. · 1992
- Descendant · cites it directly · 1 of its ownK983662 C.T.M. Mobility Scooter, Model # HS-686Warepalmy Enterprise, LLC (Usa) · 1998
- Descendant · cites it directly · 1 of its ownK971387 Freerider, Model FR510-FFreerider USA, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK133187 FREERIDER FR1, models FR1-13, FR1-15, FR1-17Freerider Corp · 2015
- Descendant · 2 generations on · 0 of its ownK033116 Opti-Rider DeluxeHansung Econet Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK983663 C.T.M. Mobility Scooter, Model # HS-666Warepalmy Enterprise, LLC (Usa) · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K983662C.T.M. Mobility Scooter, Model # HS-686Warepalmy Enterprise, LLC (Usa) · 1998 · cites it directly1descendant
- K971387Freerider, Model FR510-FFreerider USA, Inc. · 1997 · cites it directly1descendant
- K133187FREERIDER FR1, models FR1-13, FR1-15, FR1-17Freerider Corp · 2015 · 2 generations on0descendants
- K033116Opti-Rider DeluxeHansung Econet Co., Ltd. · 2004 · 2 generations on0descendants
- K983663C.T.M. Mobility Scooter, Model # HS-666Warepalmy Enterprise, LLC (Usa) · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920654 | Shoprider - TE889 | Pride Health Care, Inc. | 1992 | — |
| +1 | K983662 | C.T.M. Mobility Scooter, Model # HS-686 | Warepalmy Enterprise, LLC (Usa) | 1998 | — |
| +1 | K971387 | Freerider, Model FR510-F | Freerider USA, Inc. | 1997 | — |
| +2 | K133187 | FREERIDER FR1, models FR1-13, FR1-15, FR1-17 | Freerider Corp | 2015 | — |
| +2 | K033116 | Opti-Rider Deluxe | Hansung Econet Co., Ltd. | 2004 | — |
| +1 | K983663 | C.T.M. Mobility Scooter, Model # HS-666 | Warepalmy Enterprise, LLC (Usa) | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K983662 (Warepalmy Enterprise, LLC (Usa), 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All INI devicesINI 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
2026 to Oct 25, outlined.
Median 510(k) review, days · INI
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INI
26in 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 | — |
https://510kreport.com/device/K920654 · printed Nov 4, 2026
Cite this page
510(k) Report. “K920654: Shoprider - TE889.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920654
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026