510(k) · Cleared
ClearedPeachtree Proportional Head Control Unit (PHC-3)
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 Sep 24, 1999 as substantially equivalent to K972147 (Dynamic Systems, Inc., 1997) and 3 other predicates after a 176-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Sep 24, 1999
- Review
- 176 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K880364 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880364 Model #1555 Remote JoystickInvacare Corp. · 1988
- This deviceK991090 Peachtree Proportional Head Control Unit (PHC-3)Dynamic Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880364 | Model #1555 Remote Joystick | Invacare Corp. | 1988 | — |
| 0 (this device) | K991090 | Peachtree Proportional Head Control Unit (PHC-3) | Dynamic Systems, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K972147 | Peachtree Proportional Head Control Unit (PHC-2)Summary page 1…e PHC-3 is substantially equivalent to other legally marketed driver control systems for powered wheelchairs such as Dynamic Systems Inc.'s Peachtree Head Control PHC-2 (K972147), Adaptive Switch Lab's ASL Model #104 (K914737); Invacare's model MCC- MKIV Micro (Sip & Puff and R1M.) (K940972); and Invacare… | 1997 |
| * | K914737 | Asl Model #104Summary page 1…ally marketed driver control systems for powered wheelchairs such as Dynamic Systems Inc.'s Peachtree Head Control PHC-2 (K972147), Adaptive Switch Lab's ASL Model #104 (K914737); Invacare's model MCC- MKIV Micro (Sip & Puff and R1M.) (K940972); and Invacare's Model #1555 Remote Joystick (K880364). === P… | 1992 |
| * | K940972 | Model MCC - Mkiv Micro Computer ControlsSummary page 1…s Dynamic Systems Inc.'s Peachtree Head Control PHC-2 (K972147), Adaptive Switch Lab's ASL Model #104 (K914737); Invacare's model MCC- MKIV Micro (Sip & Puff and R1M.) (K940972); and Invacare's Model #1555 Remote Joystick (K880364). 4 .—/é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt… | 1994 |
| * | K880364 | Model #1555 Remote JoystickSummary page 1…(K972147), Adaptive Switch Lab's ASL Model #104 (K914737); Invacare's model MCC- MKIV Micro (Sip & Puff and R1M.) (K940972); and Invacare's Model #1555 Remote Joystick (K880364). 4 .—/é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ;} Food and Drug Administration 9200 Corpor… | 1988 |
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?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K972147.
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 model PHC-3 is intended to offer persons restricted to a seated position the ability to operate a powered wheelchair by three different methods. The first is & non-contact, fully proportional head movement commanded driving control. The next is controlied by a series of blowing and inhaling into a straw. This allows for four way directional control of the wheelchair. The last driving method uses a combination of…
Read the full statement (126 words)
The Peachtree Proportional Head Control model PHC-3 is intended to offer persons restricted to a seated position the ability to operate a powered wheelchair by three different methods. The first is & non-contact, fully proportional head movement commanded driving control. The next is controlied by a series of blowing and inhaling into a straw. This allows for four way directional control of the wheelchair. The last driving method uses a combination of the two previous drive controls, The user would tilt their had laterally to move the wheelchair left or right and blow or inhale into the straw to control forward/reverse direction/speed.
At current the PHC-3 has only been made to be compatible with Invacare's MKIV series of electronics and Dynamic Controls DX series of electronics.
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/K991090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991090: Peachtree Proportional Head Control Unit (PHC-3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991090
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