Cleared Traditional

K872093 - RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING

K872093 · Ics Medical Corp. · Ear, Nose, Throat device
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Sep 1987
Decision
107d
Days
-
Risk

K872093 is an FDA 510(k) clearance for the RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on September 16, 1987 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Ics Medical Corp. devices

FDA 510(k) Submission Details - K872093

510(k) Number K872093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date September 16, 1987
Days to Decision 107 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 90d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

LXV Device Classification - Class 0,

Product Code LXV Apparatus, Vestibular Analysis
Device Class -