510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910819Substantially Equivalent

Companion Speech Aid, Model 160

Companion Products Intl., Coyote CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910819 is the FDA 510(k) clearance record for COMPANION SPEECH AID, MODEL 160, a class II device, cleared for Companion Products Intl. on under FDA product code ILQ (System, Communication, Powered). FDA records list 2 510(k) clearances for Companion Products Intl. As of , FDA records show no recalls naming K910819.

Clearance record

Decision date
Received
(9 days to decision)
Product code
ILQ System, Communication, Powered
Regulation
21 CFR 890.3710
Device class
Class II
Review panel
Physical Medicine
Applicant
Companion Products Intl. P.O. Box 13133, Coyote CA
Third party review
No

Clearances, product code ILQ

Trailing 12 months

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

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