510(k) · Cleared
ClearedBariatric Power Positioning System (BPPS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motion Concepts · ITI Wheelchair, Powered
Cleared on Mar 8, 2019 as substantially equivalent to K150574 (Motion Concepts, 2015) after a 129-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Mar 8, 2019
- Review
- 129 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960951 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 3 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- 2 generations backK021264 TRZ-CG Power Positioning System with Center-of-Gravity Shifting…Motion Concepts · 2002
- 1 generation backK150574 Modular Power Positioning SystemMotion Concepts · 2015
- This deviceK182995 Bariatric Power Positioning System (BPPS)Motion Concepts · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −3 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| −2 | K021264 | TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt… | Motion Concepts | 2002 | — |
| −1 | K150574 | Modular Power Positioning System | Motion Concepts | 2015 | — |
| 0 (this device) | K182995 | Bariatric Power Positioning System (BPPS) | Motion Concepts | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K150574 | Modular Power Positioning SystemSummary page 4…vice: Class II III. PREDICATE DEVICE The predicate device is the Motion Concepts Modular Power Positioning System (MPPS) cleared under K150574. IV. DEVICE DESCRIPTION The Bariatric Power Positioning System (BPPS) is a seating system which is added to a power… | 2015 |
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 22 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K150574.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Bariatric Power Positioning System is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. - Benefits associated with the tilt/recline product: • Comfort — as with any individual – able-bodied or disabled – changes in position are necessary to maintain a state of comfort. • Positioning — Individuals without adequate upper-body…
Read the full statement (166 words)
The Bariatric Power Positioning System is appropriate for use by any individual who drives a power wheelchair and who
desires or requires a change of position without having to utilize the services of an attendant.
- Benefits associated with the tilt/recline product:
• Comfort — as with any individual – able-bodied or disabled – changes in position are necessary to maintain a state of
comfort.
• Positioning — Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
• Pressure Relief or Reduction — Individuals who wish, from time to time, to redistribute pressure from one area of the
body to another, can do so by tilting and/or reclining. By changing the individual’s orientation in space, pressures caused
by gravity will shift.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182995: Bariatric Power Positioning System (BPPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182995
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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