510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801628Substantially Equivalent

Restraint, Protective

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

K801628 is the FDA 510(k) clearance record for RESTRAINT, PROTECTIVE, a class I device, cleared for The Owenby Co. on under FDA product code IQK (Orthosis, Cervical). FDA records list 14 510(k) clearances for The Owenby Co., from to . As of , FDA records show no recalls naming K801628.

Clearance record

Decision date
Received
(23 days to decision)
Product code
IQK Orthosis, Cervical
Regulation
21 CFR 890.3490
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 IQK

Trailing 12 months

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

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