510(k) · Cleared
ClearedPeachtree Proportional Head Control Unit (PHC-2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynamic Systems, Inc. · ITI Wheelchair, Powered
Cleared on Aug 25, 1997 after a 77-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 25, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK972147 Peachtree Proportional Head Control Unit (PHC-2)Dynamic Systems, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK073330 Freedom Sciences Motion Control Module (MCM)Freedom Sciences, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK091723 Freedom Sciences Motion Control Module Version 1.5Freedom Sciences, LLC · 2009
- Descendant · cites it directly · 0 of its ownK991090 Peachtree Proportional Head Control Unit (PHC-3)Dynamic Systems, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See all- K073330Freedom Sciences Motion Control Module (MCM)Freedom Sciences, LLC · 2008 · cites it directly1descendant
- K091723Freedom Sciences Motion Control Module Version 1.5Freedom Sciences, LLC · 2009 · 2 generations on0descendants
- K991090Peachtree Proportional Head Control Unit (PHC-3)Dynamic Systems, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972147 | Peachtree Proportional Head Control Unit (PHC-2) | Dynamic Systems, Inc. | 1997 | — |
| +1 | K073330 | Freedom Sciences Motion Control Module (MCM) | Freedom Sciences, LLC | 2008 | — |
| +2 | K091723 | Freedom Sciences Motion Control Module Version 1.5 | Freedom Sciences, LLC | 2009 | — |
| +1 | K991090 | Peachtree Proportional Head Control Unit (PHC-3) | Dynamic Systems, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (4)
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 |
|---|---|---|---|
| * | — | Adaptive Switch Laboratories, Inc.’s ASL Head Array Named without a submission number | |
| * | — | Invacare’s Sip & Puff Head Array Named without a submission number | |
| * | — | Invacare’s Remote Joystick Named without a submission number | |
| * | — | Invacare’s R.I.L.M. control Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K073330 (Freedom Sciences, LLC, 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Peachtree Proportional Head Control Unit is
non-contact, fully proportional, head movement commanded driving control
intended to provide mobility control to persons restricted to a seated position while
operating a variety of available power-drive wheelchairs.
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/K972147 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972147: Peachtree Proportional Head Control Unit (PHC-2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972147
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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