Cleared Traditional

K003644 - EYETECT TREMOR MONITOR UNIT (TMU)

K003644 is an FDA 510(k) clearance for EYETECT TREMOR MONITOR UNIT (TMU), manufactured by Eyetect, LLC. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K003644 · Eyetect, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
66d
Days
Class 2
Risk

K003644 is an FDA 510(k) clearance for the EYETECT TREMOR MONITOR UNIT (TMU). Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Eyetect, LLC (Belleville,, US). The FDA issued a Cleared decision on February 1, 2001 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K003644

510(k) Number K003644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2000
Decision Date February 01, 2001
Days to Decision 66 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
83d faster than avg
Panel avg: 149d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 59
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K003644.
BALANCEBACK VNG SYSTEM
K042529 · Fall Prevention Technologies, LLC · Oct 2004
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
K013060 · Ics Medical · Dec 2001
ENGPLUS
K010059 · Western Systems Research, Inc. · Feb 2001
EXPRESSEYE
K992473 · Optomotor Laboratories · Aug 1999
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
K991642 · Bertec Corp. · Aug 1999
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
K991497 · Ics Medical Corp. · Jul 1999
K003644 · EYETECT TREMOR MONITOR UNIT (TMU)
Download PDF FDA Summary Eyetect, LLC