510(k) · Cleared
ClearedErgoSteel (ES0001/696)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Strongback Mobility AG C/O Blueaudit GmbH · IOR Wheelchair, Mechanical
Cleared on Sep 22, 2026 as substantially equivalent to K231320 (Zhenjiang Assure Medical Equipment Co., Ltd., 2023) after a 301-day review. Its family tree reaches back 9 generations to 2002.
- Decided
- Sep 22, 2026
- Review
- 301 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K020472 (2002). No later device cites it as a predicate yet.
- Root · 9 generations backK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
- 5 generations between
- 3 generations backK101999 Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010
- 2 generations backK112816 Zhenjiang Asure Mechanical WheelchairZhenjiang Assure Medical Equipment Co., Ltd. · 2012
- 1 generation backK231320 Zhenjiang Assure Mechanical Wheelchair,model:K1Zhenjiang Assure Medical Equipment Co., Ltd. · 2023
- This deviceK253762 ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbH · 2026
Show all 9 generations
- Root · 9 generations backK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
- 8 generations backK041337 Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004
- 7 generations backK050290 Lerado, CoscoLerado Oversea Ltd. Twn Branch (Bvi) · 2005
- 6 generations backK050708 Lerado, Avanticare Mechanical Wheelchair, MR-9000Lerado Oversea Ltd. Twn Branch (Bvi) · 2005
- 5 generations backK051482 Jan Mao Wheelchair, Model JMC612-F18EPPJan Mao Industries Co., Ltd. · 2005
- 4 generations backK062218 Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPJan Mao Industries Co., Ltd. · 2006
- 3 generations backK101999 Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010
- 2 generations backK112816 Zhenjiang Asure Mechanical WheelchairZhenjiang Assure Medical Equipment Co., Ltd. · 2012
- 1 generation backK231320 Zhenjiang Assure Mechanical Wheelchair,model:K1Zhenjiang Assure Medical Equipment Co., Ltd. · 2023
- This deviceK253762 ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K020472 | Biotech Manual Wheelchair B900 Super Light Wheelchair | Taiwan Armada Enterprise Co., Ltd. | 2002 | — |
| −8 | K041337 | Pro Walker ML-300 Foldable Wheelchair | Pro Walker, Inc. | 2004 | — |
| −7 | K050290 | Lerado, Cosco | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| −6 | K050708 | Lerado, Avanticare Mechanical Wheelchair, MR-9000 | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| −5 | K051482 | Jan Mao Wheelchair, Model JMC612-F18EPP | Jan Mao Industries Co., Ltd. | 2005 | — |
| −4 | K062218 | Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPP | Jan Mao Industries Co., Ltd. | 2006 | — |
| −3 | K101999 | Kaiyang Steel Wheelchair | Guangdong Kaiyang Medical Technology Co., Ltd. | 2010 | — |
| −2 | K112816 | Zhenjiang Asure Mechanical Wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | 2012 | — |
| −1 | K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023 | — |
| 0 (this device) | K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | 2026 | — |
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 |
|---|---|---|---|
| * | K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1Summary page 5…IOR Regulatory class Class I 3. Legally marketed predicate device — 21 CFR 807.92(a)(3) 510(k) number K231320 Device Zhenjiang Assure Mechanical Wheelchair, Model K1 Product code IOR… | 2023 |
| † | K131529 | Shengguang Manual Wheelchair | 2013 |
| † | K010094 | A & I Wheelchairs | 2001 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- None of the 9 ancestors has a recall.
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 device is intended for medical purpose to provide mobility to persons restricted to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253762: ErgoSteel (ES0001/696).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253762
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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