510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801627Substantially Equivalent

Cover, Limb

The Owenby Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801627 is the FDA 510(k) clearance record for COVER, LIMB, a class I device, cleared for The Owenby Co. on under FDA product code IPM (Cover, Limb). FDA records list 14 510(k) clearances for The Owenby Co., from to . As of , FDA records show no recalls naming K801627.

Clearance record

Decision date
Received
(13 days to decision)
Product code
IPM Cover, Limb
Regulation
21 CFR 890.3025
Device class
Class I
Review panel
Physical Medicine
Applicant
The Owenby Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IPM

Trailing 12 months

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

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