510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820444Substantially Equivalent

Heart-Alert

Medical Equipment Devices, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820444 is the FDA 510(k) clearance record for HEART-ALERT, a class I device, cleared for Medical Equipment Devices, Inc. on under FDA product code KHX (Platform, Force-Measuring). FDA records list one 510(k) clearance for Medical Equipment Devices, Inc. As of , FDA records show no recalls naming K820444.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KHX Platform, Force-Measuring
Regulation
21 CFR 890.1575
Device class
Class I
Review panel
Physical Medicine
Applicant
Medical Equipment Devices, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KHX

Trailing 12 months

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

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