510(k) · Cleared
ClearedEmpulse R90
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical (Us), LLC · ITI Wheelchair, Powered
Cleared on Mar 30, 2022 as substantially equivalent to K151199 (Max Mobility, LLC, 2015) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 2000. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 30, 2022
- Review
- 63 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001491 (2000). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK001491 Quickie 2 Power Assist WheelchairSunrise Medical, Inc. · 2000
- 1 generation backK140204 JWX-2Yamaha Motor Co., Ltd. · 2014
- This deviceK220213 Empulse R90Sunrise Medical (Us), LLC · 2022
Class I recalls in this family
- K151199 SmartDrive Wheelchair Power Assistdirect predicate · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001491 | Quickie 2 Power Assist Wheelchair | Sunrise Medical, Inc. | 2000 | — |
| −1 | K140204 | JWX-2 | Yamaha Motor Co., Ltd. | 2014 | — |
| 0 (this device) | K220213 | Empulse R90 | Sunrise Medical (Us), LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2015 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K151199 | SmartDrive Wheelchair Power AssistSummary page 4…ulse R90 is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K151199 Smart Drive MX2 / Max Mobility (Permobil) K140204 JWX-2 (Navione) / Yamaha DEVICE DESCRIPTION The Emp… | 2015 |
| * | K140204 | JWX-2Summary page 4…s: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K151199 Smart Drive MX2 / Max Mobility (Permobil) K140204 JWX-2 (Navione) / Yamaha DEVICE DESCRIPTION The Empulse R90 is an auxiliary power module to provide augmented powe… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151199SmartDrive Wheelchair Power AssistMax Mobility, LLC · 2015 · Direct predicate · ◆ in the 2015 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K151199.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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?
The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
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/K220213 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220213: Empulse R90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220213
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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