510(k) · Cleared
ClearedIvoc- Integrated Voice Operated Control Unit (Ivoc-1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interactive Living Systems, Inc. · LFF Unit, Activation, Breath Control
Cleared on Aug 31, 1998 after a 627-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 31, 1998
- Review
- 627 days
- Class
- Class I
- Product code
- LFF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFF? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LFF devicesLFF Unit, Activation, Breath Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFF
FDA has decided no LFF device since 2007.
Median 510(k) review, days · LFF
Too few LFF 510(k)s in any year since 2007 to give a median.
Recalls per year · LFF
No recall names LFF since 2007.
Adverse event reports per year · LFF
3in 2007
MAUDE reports naming product code LFF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 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?
IVOC—Integrated Voice Operated Control system for electric wheelchairs, allows the octupant to control movement of their chair by using voice commands.
Controllers. The user’s wheelchair must have one of the following controllers:
A. Invacare MK 1V controller.
B. Everest and Jennings Z-51 or Z-61 controller.
C. Quickie P100, P200, or P300 controller.
D. Dynamic Controls Ltd. DX-Power controller.
Vocal Capability. The User must have the ability to consistently reproduce a series commands or sounds.
Emergency Stop Switch. The User must have the capability to activate a manual Emergency Stop Switch.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964977: Ivoc- Integrated Voice Operated Control Unit (Ivoc-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964977
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026