# K091682: LSVT C or LSVT Companion, Model V.1

- Pathway: 510(k) (Traditional)
- Applicant: Lsvt Global, LLC
- Decided: Aug 20, 2009 after 71 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: 2 generations back to K802870 (1980). 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)
- K982396: Visivox, Model V-2, Rsq, LLC (1998) Summary page 2.

## Indications for use
The LSVT Companion Device is designed: To be used as a technical-aid complementing person-to-person speech therapy to improve the vocal loudness of persons with Parkinson's disease. To be used with adults, 18 years of age or older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes. To be used for voice/speech impaired adults, 18 years of age and older, who are able to follow the directions of a Speech-Language Pathologist. This device is sold only to licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol. This certifies them to. provide LSVT for patients with Parkinson's disease and other communicative impairments. The following specific labeling, therefore, is provided on the product: Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner. The LSVT Companion is designed as a technical aid for this behavioral intervention to increase communicative effectiveness. A "home study" function allows patients to complete voice exercises either under direct supervision by the practitioner in the clinic environment or at home, with feedback of performance provided to the clinician by results reporting via e-mail.

Source page: https://510kreport.com/device/K091682
Methodology: https://510kreport.com/methodology