# K033819: Invacare 3G Tarsys

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Jun 4, 2004 after 178 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972563 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991119: Tilt/Recliner for Power Wheelchairs, Model 2G, Invacare Corp. (1999) Summary page 2.
- K013516: Invacare Elevating Seat Option ESS6, Invacare Corp. (2001) Summary page 2.
- K021264: TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and Power Elevating Seat, Motion Concepts (2002) Summary page 2.

## Indications for use
The intended fruction of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate f1metion is intended primarily to provide powered elevation of the wheelchair seat and user in order to assist tLhe user wit1i daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tilt-only and recline only versions are rated for a combined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.

Source page: https://510kreport.com/device/K033819
Methodology: https://510kreport.com/methodology