# K101277: Orion II (Heavy Duty 350 LBS and 500 LBS)

- Pathway: 510(k) (Special)
- Applicant: Future Mobility Healthcare, Inc.
- Decided: Jun 4, 2010 after 29 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K061010: Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical Wheelchair, Future Mobility Healthcare, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K170517: Merits Model R106/R136 Rehab Wheelchair (2017), 3 descendants of its own
- K252828: Manual Wheelchair (W47) (2025), 0 descendants of its own
- K200466: Manual Wheelchair (Model W28) (2021), 0 descendants of its own
- K180309: Manual Wheelchair W54 (2019), 0 descendants of its own

## Indications for use
To provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K101277
Methodology: https://510kreport.com/methodology