510(k) · Cleared
ClearedA-200 Powered Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Healthcare LP · ITI Wheelchair, Powered
Cleared on Dec 27, 2005 as substantially equivalent to K000739 (Otto Bock Orthopedic Industry, Inc., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 27, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000739 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000739 Evantgarde/Endeavor Powered WheelchairOtto Bock Orthopedic Industry, Inc. · 2000
- This deviceK052706 A-200 Powered WheelchairOtto Bock Healthcare LP · 2005
- Descendant · cites it directly · 0 of its ownK173313 SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI…Eurogreen International, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK070318 Skippi Powered Wheelchair for ChildrenOtto Bock Healthcare LP · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000739 | Evantgarde/Endeavor Powered Wheelchair | Otto Bock Orthopedic Industry, Inc. | 2000 | — |
| 0 (this device) | K052706 | A-200 Powered Wheelchair | Otto Bock Healthcare LP | 2005 | — |
| +1 | K173313 | SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP | Eurogreen International, Inc. | 2018 | — |
| +1 | K070318 | Skippi Powered Wheelchair for Children | Otto Bock Healthcare LP | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K000739 | Evantgarde/Endeavor Powered WheelchairSummary page 2…FE C. Identification of Legally Marketed IDevices 1.Name: Evantgarde/Eiideavor/A-1I00 2. K Number: K000739 3. Date Cleared: October 24, 2000 D. Description of the Device The A-200 Powered Wheelchair is… | 2000 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K173313 (Eurogreen International, Inc., 2018) has gone furthest, with 0 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.
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 | — |
What is it indicated for?
Provide mobility to persons physically challenged and limited to sitting positions.
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/K052706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052706: A-200 Powered Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052706
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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