510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930044Substantially Equivalent

Comfort Keyboard System

Health Care Keyboard Co., Inc., Menomonee Falls WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930044 is the FDA 510(k) clearance record for COMFORT KEYBOARD SYSTEM, a class II device, cleared for Health Care Keyboard Co., Inc. on under FDA product code ILQ (System, Communication, Powered). FDA records list one 510(k) clearance for Health Care Keyboard Co., Inc. As of , FDA records show no recalls naming K930044.

Clearance record

Decision date
Received
(555 days to decision)
Product code
ILQ System, Communication, Powered
Regulation
21 CFR 890.3710
Device class
Class II
Review panel
Physical Medicine
Applicant
Health Care Keyboard Co., Inc. N82 W15340 Appleton Ave., Menomonee Falls WI
510(k) summary
Summary
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