510(k) · Cleared
ClearedFuture Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Future Mobility Healthcare, Inc. · IOR Wheelchair, Mechanical
Cleared on May 23, 2006 as substantially equivalent to K951138 (Invacare Corp., 1995) after a 41-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- May 23, 2006
- Review
- 41 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951138 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951138 Models Phoenix and Concept 45 Manual Mechanical WheelchairsInvacare Corp. · 1995
- This deviceK061010 Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato…Future Mobility Healthcare, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK103073 Super Chair for Kids by OrionFuture Mobility Healthcare, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK102031 Galaxy LiteFuture Mobility Healthcare, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951138 | Models Phoenix and Concept 45 Manual Mechanical Wheelchairs | Invacare Corp. | 1995 | — |
| 0 (this device) | K061010 | Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical… | Future Mobility Healthcare, Inc. | 2006 | — |
| +1 | K103073 | Super Chair for Kids by Orion | Future Mobility Healthcare, Inc. | 2011 | — |
| +1 | K102031 | Galaxy Lite | Future Mobility Healthcare, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K951138 | Models Phoenix and Concept 45 Manual Mechanical Wheelchairs | 1995 |
What descends from it? (2)
2 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?
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Future Mobility HealthCare Inc. Orion II Wheelchair is intended to provide
mobility to persons limited to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061010 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061010: Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061010
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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