# K182946: Invacare TDX SP2-HD with Captain's Seat

- Pathway: 510(k) (Special)
- Applicant: Invacare Corporation
- Decided: Dec 11, 2018 after 49 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: 7 generations back to K900565 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170507: Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx, Invacare Corporation (2017) Summary page 4.

## Indications for use
The indication for use of the Invacare® TDX® SP2-HD with Captain’s Seat is to provide mobility and positioning to persons limited to a sitting position.

Source page: https://510kreport.com/device/K182946
Methodology: https://510kreport.com/methodology