# K081665: Millenium II

- Pathway: 510(k) (Traditional)
- Applicant: Next Mobility, LLC
- Decided: Jun 27, 2008 after 14 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
Longest line of descent: 1 generation back to K935398 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935398: Tracer Series Manual Wheelchairs, Invacare Corp. (1994) Summary page 1.

## Indications for use
The Millenium wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.

Source page: https://510kreport.com/device/K081665
Methodology: https://510kreport.com/methodology