510(k) · Cleared
ClearedRuike, Model 3331
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Ruike Sports Goods Co., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Dec 14, 2006 as substantially equivalent to K060042 (Besteam Technology, Inc., 2006) after a 97-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.
- Decided
- Dec 14, 2006
- Review
- 97 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K023010 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK023010 Sniff Position Pillows/Popitz PillowsAeolus International Corporation · 2002
- 4 generations backK033241 BE-Mobile 3-Wheeled Electric Scooter, Model DK S320Tung Keng Enterprise Co., Ltd. · 2003
- 3 generations backK050792 Landlex, Model S300XCycling and Health Tech. Industry R&D Center · 2005
- 2 generations backK052378 Proasia, Model L3402Proasia Limited · 2005
- 1 generation backK060042 Landlex, Model P100XBesteam Technology, Inc. · 2006
- This deviceK062676 Ruike, Model 3331Shanghai Ruike Sports Goods Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK102358 ZIP'R3/ ZIP'R3 Xtra ScooterGlobal Fabtech Wheelchair (Shanghai) Co., Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102358ZIP'R3/ ZIP'R3 Xtra ScooterGlobal Fabtech Wheelchair (Shanghai) Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K023010 | Sniff Position Pillows/Popitz Pillows | Aeolus International Corporation | 2002 | — |
| −4 | K033241 | BE-Mobile 3-Wheeled Electric Scooter, Model DK S320 | Tung Keng Enterprise Co., Ltd. | 2003 | — |
| −3 | K050792 | Landlex, Model S300X | Cycling and Health Tech. Industry R&D Center | 2005 | — |
| −2 | K052378 | Proasia, Model L3402 | Proasia Limited | 2005 | — |
| −1 | K060042 | Landlex, Model P100X | Besteam Technology, Inc. | 2006 | — |
| 0 (this device) | K062676 | Ruike, Model 3331 | Shanghai Ruike Sports Goods Co., Ltd. | 2006 | — |
| +1 | K102358 | ZIP'R3/ ZIP'R3 Xtra Scooter | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K060042 | Landlex, Model P100XSummary page 1…ty (Panel): Physical Medicine Device Regulation number: 890.3800 Product Code: 89INI Classification: Class II Predicate devices LANDLEX P1OOX (K060042)/ Besteam Technology Inc. Intend use of device Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102358 | ZIP'R3/ ZIP'R3 Xtra Scooter | 2010 | 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?
- The line of descent spans 4 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K102358 (Global Fabtech Wheelchair (Shanghai) Co., Ltd., 2010) has gone furthest, with 0 descendants 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 | — |
What is it indicated for?
The Ruike 3331 scooter is motor driven, indoor and outdoor transportation vehicles
with the intended use to provide mobility to disabled or elderly persons limited to a
seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062676: Ruike, Model 3331.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062676
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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