# K973418: Universal/1000 Series (101S101SDU1100)/Rolls 2000(2000E)/Transport (M4)

- Pathway: 510(k) (Traditional)
- Applicant: Assembly Required Dist., Inc.
- Decided: Oct 9, 1997 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
Longest line of descent: 1 generation back to K881762 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930411: Universal Wheelchair, Everest & Jennings, Inc. (1993) Summary page 1.
- K881762: Rolls 2000 Series Wheelchair, Invacare Corp. (1988) Summary page 1.

## Indications for use
Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.

Source page: https://510kreport.com/device/K973418
Methodology: https://510kreport.com/methodology