510(k) · Cleared
ClearedIpup 200 (Intelligent Pressure Ulcer Prevention)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Technology Systems, Inc. · MOC Cushion, Flotation, Therapeutic
Cleared on Mar 14, 2008 after a 512-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 14, 2008
- Review
- 512 days
- Class
- Class II
- Product code
- MOC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MOC devicesMOC Cushion, Flotation, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MOC
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MOC
Too few MOC 510(k)s in any year since 2007 to give a median.
Recalls per year · MOC
No recall names MOC since 2007.
Adverse event reports per year · MOC
1in 2023
MAUDE reports naming product code MOC, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The iPUPc is appropriate for use by any wheelchair user, who requires regular, periodic positioning changes without the aid of an attendant. These regular, periodic positioning changes are needed for, but not limited to: Pressure relief or reduction by shifting the user's body weight from the buttocks to the thighs and the lower back. The iPUPc seating system could provide pressure relief by postural change for persons having the following condition or…
Read the full statement (113 words)
The iPUPc is appropriate for use by any wheelchair user, who requires regular, periodic positioning changes without the aid of an attendant. These regular, periodic positioning changes are needed for, but not limited to:
Pressure relief or reduction by shifting the user's body weight from the buttocks to the thighs and the lower back.
The iPUPc seating system could provide pressure relief by postural change for persons having the following condition or injury: an existing pressure sore, or an individual at extreme risk of developing a pressure sore.
Any individual who needs pressure relief through regular periodic positional changes, who is unable to do so independently, can accomplish this through the iPUPc device.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063175: Ipup 200 (Intelligent Pressure Ulcer Prevention).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063175
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026