Cleared Traditional

RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING (K872093) - FDA 510(k) Clearance

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

Submission Details

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
18d slower than avg
Panel avg: 89d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -

Regulatory Peers - LXV Apparatus, Vestibular Analysis

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