510(k) · Cleared
ClearedFreedom Sciences Motion Control Module Version 1.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Freedom Sciences, LLC · ITI Wheelchair, Powered
Cleared on Jul 6, 2009 as substantially equivalent to K073330 (Freedom Sciences, LLC, 2008) after a 25-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jul 6, 2009
- Review
- 25 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881463 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK881463 Multimode (TM) Power Module SystemDufco Electronics, Inc. · 1988
- 2 generations backK983520 Breath Control (Breath Actuator), Sensitouch Breath Control, Head…Sunrise Medical, Inc. · 1998
- 1 generation backK073330 Freedom Sciences Motion Control Module (MCM)Freedom Sciences, LLC · 2008
- This deviceK091723 Freedom Sciences Motion Control Module Version 1.5Freedom Sciences, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881463 | Multimode (TM) Power Module System | Dufco Electronics, Inc. | 1988 | — |
| −2 | K983520 | Breath Control (Breath Actuator), Sensitouch Breath Control, Head Array… | Sunrise Medical, Inc. | 1998 | — |
| −1 | K073330 | Freedom Sciences Motion Control Module (MCM) | Freedom Sciences, LLC | 2008 | — |
| 0 (this device) | K091723 | Freedom Sciences Motion Control Module Version 1.5 | Freedom Sciences, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K073330 | Freedom Sciences Motion Control Module (MCM)Summary page 2…Freedom Sciences MCM vl.5 Motion Control Module is substantially equivalent to the Freedom Sciences Motion Control Module (MCM) for powered wheelchairs (K073330). Performance Data The MCM vl.5 was tested as required by FDA's July 26, 1995, draft publication entitl… | 2008 |
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 21 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 intended use of the Freedom Sciences version 1.5 Motion Control Module is to allow for remote motion control of a powered wheelchairs while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM Version 1.5 is compatible with powered wheelchairs that use Invacare MK6 Electronics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091723: Freedom Sciences Motion Control Module Version 1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091723
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