510(k) · Cleared
ClearedMerits Model R106/R136 Rehab Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merits Healthcare Industries (Suzhou) Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Nov 16, 2017 as substantially equivalent to K101277 (Future Mobility Healthcare, Inc., 2010) after a 268-day review. Its family tree reaches back 1 generation to 2010. 3 later devices descend from it.
- Decided
- Nov 16, 2017
- Review
- 268 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101277 (2010). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK101277 Orion II (Heavy Duty 350 LBS and 500 LBS)Future Mobility Healthcare, Inc. · 2010
- This deviceK170517 Merits Model R106/R136 Rehab WheelchairMerits Healthcare Industries (Suzhou) Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK252828 Manual Wheelchair (W47)Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK200466 Manual Wheelchair (Model W28)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK180309 Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K252828Manual Wheelchair (W47)Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd. · 2025 · cites it directly0descendants
- K200466Manual Wheelchair (Model W28)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2021 · cites it directly0descendants
- K180309Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101277 | Orion II (Heavy Duty 350 LBS and 500 LBS) | Future Mobility Healthcare, Inc. | 2010 | — |
| 0 (this device) | K170517 | Merits Model R106/R136 Rehab Wheelchair | Merits Healthcare Industries (Suzhou) Co., Ltd. | 2017 | — |
| +1 | K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd. | 2025 | — |
| +1 | K200466 | Manual Wheelchair (Model W28) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2021 | — |
| +1 | K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K101277 | Orion II (Heavy Duty 350 LBS and 500 LBS)Summary page 5…ion indicates the Substantial Equivalence of the Merits Model R106/R136 Rehab Wheelchair, with the predicate ORION Ⅱ(Heavy Duty 350lbs and 500lbs) mechanical wheelchair (K101277). R106/R136 has the same intended uses and similar indications, technological characteristics and principles of operation with pr… | 2010 |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K252828 (Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Merits Model R106/R136 Rehab Wheelchair is to provide mobility to persons limited to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170517: Merits Model R106/R136 Rehab Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170517
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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