510(k) · Cleared
ClearedBOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
21st Century Scientific, Inc. · ITI Wheelchair, Powered
Cleared on Sep 3, 2020 as substantially equivalent to K092225 (Amylior, Inc., 2009) after a 255-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Sep 3, 2020
- Review
- 255 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K900565 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
- 5 generations backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
- 4 generations backK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
- 3 generations backK012909 Xterra GT Power WheelchairInvacare Corp. · 2001
- 2 generations backK023589 Storm TDX Power WheelchairInvacare Corp. · 2002 · Recalled
- 1 generation backK092225 Amypower All Track Series Power WheelchairAmylior, Inc. · 2009
- This deviceK193599 BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair…21st Century Scientific, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| −5 | K982064 | Action Storm Ranger II, Action Storm Power 9000 | Invacare Corp. | 1998 | — |
| −4 | K991168 | Arrow FWD Power Wheelchair | Invacare Corp. | 1999 | 2 |
| −3 | K012909 | Xterra GT Power Wheelchair | Invacare Corp. | 2001 | — |
| −2 | K023589 | Storm TDX Power Wheelchair | Invacare Corp. | 2002 | 7 |
| −1 | K092225 | Amypower All Track Series Power Wheelchair | Amylior, Inc. | 2009 | — |
| 0 (this device) | K193599 | BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450… | 21st Century Scientific, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K092225 | Amypower All Track Series Power WheelchairSummary page 5…...: Physically Challenged Persons PREDICATE DEVICE per 21 CFR 807.92 (a) (3) Name of Device............................: AMYPOWER ALLTRACK Series Power Wheelchair (K092225) Common or Usual Name............: Wheelchair, Powered Classification Name....................: Powered Wheelc… | 2009 |
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 3 of the 8 ancestors have a recall of any class.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 indication for use of the BOUNDER Power Wheelchair is to provide mobility to persons limited to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193599: BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193599
Report an extraction error
Are you the manufacturer?
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