# K982396: Visivox, Model V-2

- Pathway: 510(k) (Traditional)
- Applicant: Rsq, LLC
- Decided: Sep 14, 1998 after 67 days
- Product code: LEZ (Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact))
- Device class: U
- 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 K802870 (1980). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802870: Rion Electro-Palatograph Model DP-01, Kindel & Anderson (1980) Summary page 2.

## Most influential descendants
- K091682: LSVT C or LSVT Companion, Model V.1 (2009), 0 descendants of its own

## Indications for use
To be used as an assistive device and training aid, complementing person-to-person speech therapy: 1.For the deaf, and for people with hearing impairments who do not perceive the loudness of their speech. 2.For people with speech impairments who are unable to speak at a consistent and audible level of loudness. The impairments may be due to stroke,Parkinsons’, traumatic head or spine injuries, cleft palate, laryngectomies or other causes. 3.For speech- and/or hearing impaired people of any age who are able to follow the directions of a speech therapist or audiologist.

Source page: https://510kreport.com/device/K982396
Methodology: https://510kreport.com/methodology