Cleared Traditional

DORMIE NECK SUPPORT SYSTEM (K930730) - FDA 510(k) Clearance

Class I Physical Medicine device.

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

Submission Details

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.

Device Classification

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.