Cleared Traditional

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

K930730 · The Western Diagnostics Co. · Physical Medicine device

Jul 1993

Decision

161d

Days

Class 1

Risk

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

Submitted by The Western Diagnostics Co. (West Palm Beach, US). The FDA issued a Cleared decision on July 22, 1993, 161 days after receiving the submission on February 11, 1993.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.

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