510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790954Substantially Equivalent

Heel Gard

Fem-Gard, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790954 is the FDA 510(k) clearance record for HEEL GARD, a class I device, cleared for Fem-Gard, Inc. on under FDA product code FRK (Chair, Examination And Treatment). FDA records list 2 510(k) clearances for Fem-Gard, Inc. As of , FDA records show no recalls naming K790954.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FRK Chair, Examination And Treatment
Regulation
21 CFR 880.6140
Device class
Class I
Review panel
General Hospital
Applicant
Fem-Gard, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FRK

Trailing 12 months

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

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