# K063175: Ipup 200 (Intelligent Pressure Ulcer Prevention)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Technology Systems, Inc.
- Decided: Mar 14, 2008 after 512 days
- Product code: MOC (Cushion, Flotation, Therapeutic)
- Device class: 2
- Regulation: 21 CFR 890.5170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K063175
Methodology: https://510kreport.com/methodology