510(k) · Cleared
ClearedUrok Rocking Wheelchair, Model 700-4XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amg Medical, Inc. · IOR Wheelchair, Mechanical
Cleared on Jan 6, 2006 as substantially equivalent to K902438 (The RX Rocker Corp., 1990) after a 112-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jan 6, 2006
- Review
- 112 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902438 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902438 RX Rocker WheelchairThe RX Rocker Corp. · 1990
- This deviceK052548 Urok Rocking Wheelchair, Model 700-4XXAmg Medical, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902438 | RX Rocker Wheelchair | The RX Rocker Corp. | 1990 | — |
| 0 (this device) | K052548 | Urok Rocking Wheelchair, Model 700-4XX | Amg Medical, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K902438 | RX Rocker WheelchairSummary page 1…Wheelchair Classification Name: Wheelchair, Mechanical 891OR Predicate Devices: The URok Rocking Wheelchair is substantially equivalent to the RxRocker (K902438) wheelchair for the rocking feature. The URok Rocking Wheelchair is substantially equivalent to the Invacare Solara wheelchair f… | 1990 |
| * | — | Invacare Solara wheelchair Named without a submission number |
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 IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 URok Rocking Wheelchair, by AMG Medical Inc., is intended to provide mobility to
persons limited to a sitting position while the rocking mechanism is locked in an upright
position.
The wheelchair is intended to redistribute pressures exerted on the buttocks and lower back
when rocking or tilted at an angle.
The wheelchair is intended to provide comfort adjustment while rocking or tilted at an angle.
AMG Medical inc. recommends that an accredited rehabilitation or occupational therapist
and supplier evaluate all customers of its products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052548: Urok Rocking Wheelchair, Model 700-4XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052548
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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