510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982396Substantially Equivalent

Visivox, Model V-2

Rsq, LLC, Claremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982396 is the FDA 510(k) clearance record for VISIVOX, MODEL V-2, cleared for Rsq, LLC on under FDA product code LEZ (Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)). FDA records list one 510(k) clearance for Rsq, LLC. As of , FDA records show no recalls naming K982396.

Clearance record

Decision date
Received
(67 days to decision)
Product code
LEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Device class
Unclassified
Review panel
Unknown
Applicant
Rsq, LLC 636 Wellesley Dr., Claremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code LEZ

Trailing 12 months

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

FDA records show no clearances under product code LEZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LEZ, 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