510(k) · Cleared
ClearedRGK Daily Range Wheelchairs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rgk Wheelchairs, Ltd. · IOR Wheelchair, Mechanical
Cleared on Sep 10, 2020 as substantially equivalent to K021075 (First World Services, Inc., 2002) and 1 other predicate after a 233-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Sep 10, 2020
- Review
- 233 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021075 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK021075 Mechanical Daily Use WheelchairFirst World Services, Inc. · 2002
- This deviceK200135 RGK Daily Range WheelchairsRgk Wheelchairs, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021075 | Mechanical Daily Use Wheelchair | First World Services, Inc. | 2002 | — |
| 0 (this device) | K200135 | RGK Daily Range Wheelchairs | Rgk Wheelchairs, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K021075 | Mechanical Daily Use WheelchairSummary page 4…IFICATION The RGK Daily Range Wheelchairs are substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K021075 Mechanical Daily Use Wheelchair / v First World Services, Inc. K123975 Quickie and Zippie Series / Sunrise Medical DEVICE DESCR… | 2002 |
| * | K123975 | Quickie & Zippie SeriesSummary page 4…o the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K021075 Mechanical Daily Use Wheelchair / v First World Services, Inc. K123975 Quickie and Zippie Series / Sunrise Medical DEVICE DESCRIPTIVE INFORMATION INTENDED USE The RGK Daily Range Wheelchairs are int… | 2013 |
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?
- 1 of the 2 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. 2020, 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 RGK Daily Range Wheelchairs are mechanical wheelchairs with wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.
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/K200135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200135: RGK Daily Range Wheelchairs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200135
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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