510(k) · Cleared
ClearedManual Wheelchair (7101L, 7102LHD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Apr 28, 2026 as substantially equivalent to K243111 (Bowhead Design Corp., 2025) after a 103-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Apr 28, 2026
- Review
- 103 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922535 (1992). 12 ancestors in all, the oldest K850536 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK922535 The TerminatorTop End Wheelchair Sports, Inc. · 1992
- 5 generations backK990157 Model Top End Terminator SS Manual WheelchairInvacare Corp. · 1999
- 4 generations backK012167 Model Top End Terminator Titanium Manual WheelchairInvacare Corp. · 2001
- 3 generations backK083231 Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTPanthera Production AB · 2009
- 2 generations backK220698 Bambino 3, S3 and S3 Swing, U3 and U3 Light, XPanthera AB · 2023
- 1 generation backK243111 Bowhead ERA WheelchairsBowhead Design Corp. · 2025
- This deviceK260121 Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922535 | The Terminator | Top End Wheelchair Sports, Inc. | 1992 | — |
| −5 | K990157 | Model Top End Terminator SS Manual Wheelchair | Invacare Corp. | 1999 | — |
| −4 | K012167 | Model Top End Terminator Titanium Manual Wheelchair | Invacare Corp. | 2001 | — |
| −3 | K083231 | Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BT | Panthera Production AB | 2009 | — |
| −2 | K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023 | — |
| −1 | K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K243111 | Bowhead ERA WheelchairsSummary page 5…e device(s) Manufacturer Predicate Device 510(k) Number Bowhead Design Corp. Bowhead ERA Wheelchairs K243111 5. Device description The Manual Wheelchairs are composite based mechanical, manually operated, wheelchairs int… | 2025 |
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 34 years and passes through 6 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
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 manual wheelchair is a manually operated wheelchair intended to be used as a means of mobility for individuals restricted 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/K260121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260121: Manual Wheelchair (7101L, 7102LHD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260121
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026