510(k) · Cleared
ClearedPowered Wheelchair DYW30A (D09)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · ITI Wheelchair, Powered
Cleared on Aug 9, 2017 after a 146-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Aug 9, 2017
- Review
- 146 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK170787 Powered Wheelchair DYW30A (D09)Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK192739 Electric Wheelchair [Models: JRWD6010/JRWD6012]Jerry Medical Instrument (Shanghai) Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK220156 Electrically Powered Wheelchair, Joy RiderTung Keng Enterprise Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK212503 HP458E Electrically Powered WheelchairKunshan Hi-Fortune Health Products Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK260335 Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243962 Electrically Powered WheelchairKunshan Hi-Fortune Health Products Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192739Electric Wheelchair [Models: JRWD6010/JRWD6012]Jerry Medical Instrument (Shanghai) Co., Ltd. · 2021 · cites it directly2descendants
- K220156Electrically Powered Wheelchair, Joy RiderTung Keng Enterprise Co., Ltd. · 2022 · cites it directly1descendant
- K212503HP458E Electrically Powered WheelchairKunshan Hi-Fortune Health Products Co., Ltd. · 2022 · cites it directly1descendant
- K260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K243962Electrically Powered WheelchairKunshan Hi-Fortune Health Products Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170787 | Powered Wheelchair DYW30A (D09) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 2017 | — |
| +1 | K192739 | Electric Wheelchair [Models: JRWD6010/JRWD6012] | Jerry Medical Instrument (Shanghai) Co., Ltd. | 2021 | — |
| +1 | K220156 | Electrically Powered Wheelchair, Joy Rider | Tung Keng Enterprise Co., Ltd. | 2022 | — |
| +1 | K212503 | HP458E Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2022 | — |
| +2 | K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026 | — |
| +2 | K243962 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (9)
5 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?
- Of its descendants, K192739 (Jerry Medical Instrument (Shanghai) Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
https://510kreport.com/device/K170787 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170787: Powered Wheelchair DYW30A (D09).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170787
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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