Cleared Traditional

K930730 - DORMIE NECK SUPPORT SYSTEM

K930730 is an FDA 510(k) clearance for DORMIE NECK SUPPORT SYSTEM, manufactured by The Western Diagnostics Co.. The device is a Class 1 Physical Medicine device with product code IQK cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K930730 · The Western Diagnostics Co. · Physical Medicine device
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Jul 1993
Decision
161d
Days
Class 1
Risk

K930730 is an FDA 510(k) clearance for the DORMIE NECK SUPPORT SYSTEM. Classified as Orthosis, Cervical (product code IQK), Class I - General Controls.

Submitted by The Western Diagnostics Co. (West Palm Beach, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 161 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all The Western Diagnostics Co. devices

FDA 510(k) Submission Details - K930730

510(k) Number K930730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date July 22, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 115d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

IQK Device Classification - Class 1, General Controls

Product Code IQK Orthosis, Cervical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IQK Orthosis, Cervical

Devices cleared under the same product code (IQK) and FDA review panel - the closest regulatory comparables to K930730.
CERVICAL COLLARS & HEAD HALTERS
K850465 · Abco Dealers, Inc. · Apr 1985
CERVICAL COLLAR
K823667 · Warm & Form, Orthopedic Materials · Dec 1982
CERVICAL COLLAR
K823161 · Warm & Form, Orthopedic Materials · Nov 1982
CONPHAR ADJUSTABLE CERVICAL COLLAR
K803147 · Conphar, Inc. · Jan 1981
COLLAR, CERVICAL, SPLIT
K780136 · Richard'S Medical Equip., Inc. · Jan 1978