Cleared Special

KOREBALANCE (KINESTHETIC ABILITY TRAINER) (K070676) - FDA 510(k) Clearance

K070676 · Sportkat, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
37d
Days
-
Risk

K070676 is an FDA 510(k) clearance for the KOREBALANCE (KINESTHETIC ABILITY TRAINER). Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Sportkat, LLC (Vista, US). The FDA issued a Cleared decision on April 18, 2007 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sportkat, LLC devices

Submission Details

510(k) Number K070676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date April 18, 2007
Days to Decision 37 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 89d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -

Regulatory Peers - LXV Apparatus, Vestibular Analysis

All 21
Devices cleared under the same product code (LXV) and FDA review panel - the closest regulatory comparables to K070676.
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