Cleared Traditional

K042529 - BALANCEBACK VNG SYSTEM

K042529 is an FDA 510(k) clearance for BALANCEBACK VNG SYSTEM, manufactured by Fall Prevention Technologies, LLC. The device is a Class 2 Neurology device with product code GWN cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K042529 · Fall Prevention Technologies, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
19d
Days
Class 2
Risk

K042529 is an FDA 510(k) clearance for the BALANCEBACK VNG SYSTEM. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Fall Prevention Technologies, LLC (Boca Raton, US). The FDA issued a Cleared decision on October 6, 2004 after a review of 19 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.

View all Fall Prevention Technologies, LLC devices

FDA 510(k) Submission Details - K042529

510(k) Number K042529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2004
Decision Date October 06, 2004
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 148d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 32
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K042529.
VisualEyes
K152112 · Interacoustics A/S · Dec 2015
EYESEECAM VHIT
K131681 · Interacoustics A/S · Sep 2013
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · Interacoustics A/S · Feb 2008
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