# K983520: Breath Control (Breath Actuator), Sensitouch Breath Control, Head Array (Switch Head Control), Tri-Switch Head Array, HD

- Pathway: 510(k) (Special)
- Applicant: Sunrise Medical, Inc.
- Decided: Nov 6, 1998 after 29 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
Longest line of descent: 1 generation back to K881463 (1988). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881463: Multimode (TM) Power Module System, Dufco Electronics, Inc. (1988) Summary page 3.
- (no number) Invacare devices listed in the predicate comparison table: named in the summary without a submission number

## Most influential descendants
- K073330: Freedom Sciences Motion Control Module (MCM) (2008), 1 descendant of its own
- K091723: Freedom Sciences Motion Control Module Version 1.5 (2009), 0 descendants of its own

## Indications for use
Alternate input devices are designed to provide those with sever physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit from a single actuating device.

Source page: https://510kreport.com/device/K983520
Methodology: https://510kreport.com/methodology