510(k) · Cleared
ClearedHELIO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motion Composites · IOR Wheelchair, Mechanical
Cleared on Dec 19, 2012 as substantially equivalent to K850536 (Motion Designs, Inc., 1985) and 1 other predicate after a 293-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it.
- Decided
- Dec 19, 2012
- Review
- 293 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850536 (1985). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK850536 Quickie WheelchairsMotion Designs, Inc. · 1985
- This deviceK120628 HELIOMotion Composites · 2012
- Descendant · cites it directly · 3 of its ownK161425 APEX Manual WheelchairMotion Composites · 2016
- Descendant · 2 generations on · 1 of its ownK243111 Bowhead ERA WheelchairsBowhead Design Corp. · 2025
- Descendant · cites it directly · 0 of its ownK260295 Helio Kids; Apex PMotion Composites · 2026
- Descendant · 3 generations on · 0 of its ownK260121 Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K161425APEX Manual WheelchairMotion Composites · 2016 · cites it directly3descendants
- K243111Bowhead ERA WheelchairsBowhead Design Corp. · 2025 · 2 generations on1descendant
- K260295Helio Kids; Apex PMotion Composites · 2026 · cites it directly0descendants
- K260121Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850536 | Quickie Wheelchairs | Motion Designs, Inc. | 1985 | — |
| 0 (this device) | K120628 | HELIO | Motion Composites | 2012 | — |
| +1 | K161425 | APEX Manual Wheelchair | Motion Composites | 2016 | — |
| +2 | K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025 | — |
| +1 | K260295 | Helio Kids; Apex P | Motion Composites | 2026 | — |
| +3 | K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K850536 | Quickie WheelchairsSummary page 1…ion. Predicate Devices The first predicate device isthe Quickie 2 wheelchair for the overall safety and effectiveness of the product: 510(K) number K850536 The second predicate device isthe Quickie carbon wheelchair for the safety and effectiveness of carbon fiber as the ma… | 1985 |
| * | K915533 | Quickie Carbon WheelchairSummary page 1…ckie carbon wheelchair for the safety and effectiveness of carbon fiber as the main material for frame and crossbrace in a mechanical wheelchair: 510(K) number K915533 Device -Description The hello is a traditional folding cross-brace wheelchair. It ismade of lightweight hi-Modulus ca… | 1992 |
What descends from it? (4)
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. 2012, 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 hello wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.
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/K120628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120628: HELIO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120628
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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