Cleared Traditional

K063872 - KINESIA

K063872 is an FDA 510(k) clearance for KINESIA, manufactured by Cleveland Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K063872 · Cleveland Medical Devices, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
98d
Days
Class 2
Risk

K063872 is an FDA 510(k) clearance for the KINESIA. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Cleveland Medical Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on April 6, 2007 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1950 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K063872

510(k) Number K063872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2006
Decision Date April 06, 2007
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 149d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYD Device Classification - Class 2, Special Controls

Product Code GYD Transducer, Tremor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1950
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GYD Transducer, Tremor

All 13
Devices cleared under the same product code (GYD) and FDA review panel - the closest regulatory comparables to K063872.
Personal Kinetigraph (PKG) System Gen 2 Plus
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PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086 · Gkc Manufacturing Pty, Ltd. · Aug 2014
TREMOROMETER
K010270 · Flexable Systems, Inc. · Jul 2001
MODEL 100 ACTIVITY MONITOR
K011429 · Telecom Medical, Inc. · Jul 2001
MM-1 MOVEMENT MONITOR
K971318 · Axon Instruments, Inc. · Jul 1997
K063872 · KINESIA
Download PDF FDA Summary Cleveland Medical Dev…