510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964977Substantially Equivalent

Ivoc- Integrated Voice Operated Control Unit (Ivoc-1)

Interactive Living Systems, Inc., Aurora CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964977 is the FDA 510(k) clearance record for IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1), a class I device, cleared for Interactive Living Systems, Inc. on under FDA product code LFF (Unit, Activation, Breath Control). FDA records list one 510(k) clearance for Interactive Living Systems, Inc. As of , FDA records show no recalls naming K964977.

Clearance record

Decision date
Received
(627 days to decision)
Product code
LFF Unit, Activation, Breath Control
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Interactive Living Systems, Inc. 14901 E. Hampden Ave.,, Aurora CO
510(k) summary
Statement
Third party review
No

Clearances, product code LFF

Trailing 12 months

FDA records hold no clearances under product code LFF in the trailing twelve months.

FDA records show no clearances under product code LFF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260