510(k) · Cleared
ClearedLSVT C or LSVT Companion, Model V.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsvt Global, LLC · LEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Cleared on Aug 20, 2009 as substantially equivalent to K982396 (Rsq, LLC, 1998) after a 71-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Aug 20, 2009
- Review
- 71 days
- Class
- Class U
- Product code
- LEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K802870 (1980). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LEZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982396 | Visivox, Model V-2Summary page 2…SVT is registered trademark by the U.S. Office of Patents. The Device Classification Name is AIDS, SPEECH TRAINING FOR THE HEARING IMPAIRED as shown in 510 (k) number K982396 for the VISIVOX for which we claim equivalence. 510(k) Summary… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LEZ devicesLEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LEZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LEZ
Too few LEZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LEZ
No recall names LEZ since 2007.
Adverse event reports per year · LEZ
No MAUDE report names LEZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (218 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091682: LSVT C or LSVT Companion, Model V.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091682
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026