510(k) · Cleared
ClearedEmpowerRide NAVIGATOR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empower Ride, LLC · IOR Wheelchair, Mechanical
Cleared on Jan 12, 2026 as substantially equivalent to K140416 (Convaid Products, Inc., 2014) and 2 other predicates after a 206-day review. Its family tree reaches back 5 generations to 2008.
- Decided
- Jan 12, 2026
- Review
- 206 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K073512 (2008). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK073512 Start JuniorOtto Bock Healthcare LP · 2008
- 4 generations backK082314 Bravoracer Pediatric Manual WheelchairOtto Bock Healthcare LP · 2008
- 3 generations backK120501 Champ Champ TransitConvaid Products, Inc. · 2012
- 2 generations backK140416 Trekker, Trekker TransitConvaid Products, Inc. · 2014
- 1 generation backK171017 Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit…Convaid Products, LLC · 2017
- This deviceK251886 EmpowerRide NAVIGATOREmpower Ride, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K073512 | Start Junior | Otto Bock Healthcare LP | 2008 | — |
| −4 | K082314 | Bravoracer Pediatric Manual Wheelchair | Otto Bock Healthcare LP | 2008 | — |
| −3 | K120501 | Champ Champ Transit | Convaid Products, Inc. | 2012 | — |
| −2 | K140416 | Trekker, Trekker Transit | Convaid Products, Inc. | 2014 | — |
| −1 | K171017 | Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T… | Convaid Products, LLC | 2017 | — |
| 0 (this device) | K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K140416 | Trekker, Trekker TransitSummary page 5…Number 890.3850 C. IDENTIFICATION OF LEGALLY MARKETED DEVICES Manufacturer Name Convaid Products LLC. Product Name Convaid Trekker Model TR12 and TR14 510K Number K140416 Product Code IOR, LBE Device Classification Classl Regulatory Number 890.3850 EmpowerRide LLC, 18874 Patrick Ave Elkhorn, NE 68… | 2014 |
| * | K171017 | Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T…Summary page 6…EMPOWER RIDE EmpowerRide LLC, Manufacturer Name Convaid Products LLC. Product Name Convaid Flyer Model FL12,FL13, FL14, FL15 and FL16 510K Number K171017 Product Code IOR, LBE Device Classification Classl Regulatory Number 890.3850 Manufacturer Name Ki Mobility LLC. Product Na… | 2017 |
| * | K151492 | KuduSummary page 6…K Number K171017 Product Code IOR, LBE Device Classification Classl Regulatory Number 890.3850 Manufacturer Name Ki Mobility LLC. Product Name R82 Kudu 510K Number K151492 Product Code IOR, LBE Device Classification Classl Regulatory Number 890.3850 18874 Patrick Ave Elkhorn, NE 68022 http://empowe… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K140416.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
The EmpowerRide NAVIGATOR is a manual wheelchair; it is intended to provide mobility to children with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.
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/K251886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251886: EmpowerRide NAVIGATOR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251886
Report an extraction error
Are you the manufacturer?
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