# K041346: Synergy Ultimate

- Pathway: 510(k) (Traditional)
- Applicant: Pride Mobility Products Corp.
- Decided: Sep 8, 2004 after 111 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: 1 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Motion Concept's TRX-CG Power Positioning System with Center-of Gravity Shifting Power Tilt, Recline, and Power Elevating Seat: named in the summary without a submission number

## Recalls of this device
- Dec 1, 2016 · Class II · Z-0942-2017: The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle.

## Indications for use
The Pride Mobility Products Corp. Synergy Ultimate is a power positioning seating system designed for users who need to operate their power chair and seating system independently without assistance from an attendant. The user is able to adjust the unit to achieve comfort, pressure relief, and necessary repositioning. The Synergy Ultimate is available with any or all of the following features: Power Tilt, Power-Elevating Seat, Power Recline, and Power Elevating Leg rests. All functions can be controlled from the user's joystick, through an attendant control device, or through an optional toggle switch. Pride Mobility Products Corp. makes no claims as to the therapeutic effectiveness of the product listed above. Pride Mobility Products Corp. strongly recommends a certified rehabilitation therapist evaluate all customers of its products.

Source page: https://510kreport.com/device/K041346
Methodology: https://510kreport.com/methodology