510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914259Substantially Equivalent

Touch Talker

Prentke Romich Co., Wooster OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914259 is the FDA 510(k) clearance record for TOUCH TALKER, a class II device, cleared for Prentke Romich Co. on under FDA product code ILQ (System, Communication, Powered). FDA records list 9 510(k) clearances for Prentke Romich Co., from to . As of , FDA records show no recalls naming K914259.

Clearance record

Decision date
Received
(157 days to decision)
Product code
ILQ System, Communication, Powered
Regulation
21 CFR 890.3710
Device class
Class II
Review panel
Physical Medicine
Applicant
Prentke Romich Co. 1022 Heyl Rd., Wooster OH
510(k) summary
Statement
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