510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820505Substantially Equivalent

Ankle/foot External

Mauch Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820505 is the FDA 510(k) clearance record for ANKLE/FOOT EXTERNAL, a class I device, cleared for Mauch Laboratories, Inc. on under FDA product code ISH (Component, External, Limb, Ankle/Foot). FDA records list one 510(k) clearance for Mauch Laboratories, Inc. As of , FDA records show no recalls naming K820505.

Clearance record

Decision date
Received
(11 days to decision)
Product code
ISH Component, External, Limb, Ankle/Foot
Regulation
21 CFR 890.3420
Device class
Class I
Review panel
Physical Medicine
Applicant
Mauch Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ISH

Trailing 12 months

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

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