Cleared Traditional

K070729 - BALANCEBACK MOBILE INTUITIVE VNG SYSTEM

K070729 is an FDA 510(k) clearance for BALANCEBACK MOBILE INTUITIVE 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 15-day FDA review.

K070729 · Fall Prevention Technologies, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
15d
Days
Class 2
Risk

K070729 is an FDA 510(k) clearance for the BALANCEBACK MOBILE INTUITIVE VNG SYSTEM. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Fall Prevention Technologies, LLC (Kettering, US). The FDA issued a Cleared decision on March 30, 2007 after a review of 15 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 - K070729

510(k) Number K070729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2007
Decision Date March 30, 2007
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 149d · This submission: 15d
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 Consultant

Intertek Testing Services
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWN Nystagmograph

All 55
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K070729.
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
K083603 · Neuro Kinetics · Aug 2009
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · Interacoustics A/S · Feb 2008
EYETRACKER/IDEAS
K070670 · S.A. Instrumentation Difra · Sep 2007
CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
K062015 · Chronos Vision · Oct 2006
FOCUS VNG/ENG TYPE 1068
K061791 · Gn Otometrics A/S · Jul 2006
DDAT OMT
K050098 · Ddat(Uk), Ltd. · May 2005
K070729 · BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
Download PDF FDA Summary Fall Prevention Techn…