# K973491: Mechanical Folding Wheel Chair

- Pathway: 510(k) (Traditional)
- Applicant: Heartway Medical Products Co., Ltd.
- Decided: Dec 4, 1997 after 80 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- 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. The FDA summary names its predicate without a number.
- (no number) Invacare Tracer Plus Series: named in the summary without a submission number
- (no number) Everest & Jennings Traveler Series: named in the summary without a submission number

## Indications for use
The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled. This device is intended to provide mobility to invalids who are otherwise incapable of ambulation with patient ambulatory assist devices. The models to be offered are of different sizes allowing for user preferance because of physical needs. Options for users include removeable armrests & detachable footrests to accomodate user requirements.

Source page: https://510kreport.com/device/K973491
Methodology: https://510kreport.com/methodology