# K162817: Noddle (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.
- Decided: Jan 18, 2017 after 104 days
- Product code: ILQ (System, Communication, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3710
- 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 K930044 (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)
- K930044: Comfort Keyboard System, Health Care Keyboard Co., Inc. (1994) Summary page 4.

## Indications for use
The Noddle™ is indicated for use by patients who have physical limitations, weaknesses, and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the Noddle™ patients should be sufficiently cognitively intact so that they can produce intentional gestures and intend to communicate with caregivers.

Source page: https://510kreport.com/device/K162817
Methodology: https://510kreport.com/methodology