# K063475: Imc-Heartway, LLC Electric Wheelchair, Model Tiara (P4AS)

- Pathway: 510(k) (Abbreviated)
- Applicant: Imc-Heart Way LLC
- Decided: Jan 23, 2007 after 68 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
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 intended use of the Model-Tiara (P4AS) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Source page: https://510kreport.com/device/K063475
Methodology: https://510kreport.com/methodology