510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930730Substantially Equivalent

Dormie Neck Support System

The Western Diagnostics Co., West Palm Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930730 is the FDA 510(k) clearance record for DORMIE NECK SUPPORT SYSTEM, a class I device, cleared for The Western Diagnostics Co. on under FDA product code IQK (Orthosis, Cervical). FDA records list one 510(k) clearance for The Western Diagnostics Co. As of , FDA records show no recalls naming K930730.

Clearance record

Decision date
Received
(161 days to decision)
Product code
IQK Orthosis, Cervical
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Applicant
The Western Diagnostics Co. 2617a Okeechobee Blvd., West Palm Beach FL
510(k) summary
Statement
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