510(k) · Cleared
ClearedBobcat DX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Enabling Designs, Ltd. · IPL Wheelchair, Standup
Cleared on Jun 26, 1997 as substantially equivalent to K942508 (Permobil AB, 1994) after a 134-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jun 26, 1997
- Review
- 134 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942508 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK942508 ROBOPermobil AB · 1994
- This deviceK970543 Bobcat DXQuest Enabling Designs, Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942508 | ROBO | Permobil AB | 1994 | — |
| 0 (this device) | K970543 | Bobcat DX | Quest Enabling Designs, Ltd. | 1997 | — |
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 IPL? 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 IPL device
- #1 K203761 ParaMotionscore 3.3 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K942508 | ROBOSummary page 1…chair, with adjustable elevator. Classification Name: Physical Medicine, powered wheelchair. Predicate Legally Marketed Device (claiming equivalence to) 510(k) Number: K942508. Trade Name: Permobil Chairman ROBO, powered wheelchair. Common Name: Powered wheelchair, with adjustable elevator. Classificati… | 1994 |
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?
- Its one ancestor has no recall.
How does its category compare?
All IPL devicesIPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPL
105in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPL
No recall names IPL since 2007.
Adverse event reports per year · IPL
5in 2025
MAUDE reports naming product code IPL, 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 | 3 | 63 | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 3 | 105 | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bobcat DX is highly manoeuvrable, electrically powered wheelchair. The unit consists of a front wheel drive chassis, enclosed in an attractive colourful fibreglass body, that is powered by a Control Dynamics DX microprocessor control unit. This control unit is controlled by a QED designed joystick, which has very sensitive buttons with good tactile feedback. The Bobcat DX comes complete with an elevating seat that allows the child independently to lower…
Read the full statement (313 words)
Bobcat DX is highly manoeuvrable, electrically powered wheelchair. The unit consists of a front wheel drive chassis, enclosed in an attractive colourful fibreglass body, that is powered by a Control Dynamics DX microprocessor control unit. This control unit is controlled by a QED designed joystick, which has very sensitive buttons with good tactile feedback. The Bobcat DX comes complete with an elevating seat that allows the child independently to lower themselves to the floor, or to raise themselves to table height. There are many seating options available and we also supply a standing frame.
The child can easily adjust both sitting-and standing heights, enabling participation at a table or bar-for meals. Exclusion from normal eating areas and the necessity to have cumbersome trays or special furniture become things of the past. Playing on the floor and outdoors encourages independence for the child, leaving parents and carers free to continue with family socialising and household tasks, knowing that their child can move freely at will. With most activities pressure to assist is reduced merely to supervising normal play and development.
The highly manocuvrable Bobcat DX enables children to determine their own activities without asking or waiting for assistance. Simultaneous development, emotional and physical, with their able bodied peer group removes the inevitable frustration which would otherwise set in.
Transporting the Bobcat DX presents no difficulty with the easily removable scat, remote drive panel and compact size of the unit. Benefits include:
* QED offers a wide range of seating options.
¢ Dynamic DX control system enables the Bobcat DX to be used successfully within the school, home or outdoor.
¢ Three dimensional movement reduces the need for carer participation in many activities.
e Easy ‘break-down’ for transport in the back of estate car.
¢ Accessories available including trays, lights and indicators and ramps.
¢ Suitable for users up to 12 stone (75kg) in weight.
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/K970543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970543: Bobcat DX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970543
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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