Cleared Traditional

K071661 - ALPHAONE BIOFEEDBACK SYSTEM

K071661 is an FDA 510(k) clearance for ALPHAONE BIOFEEDBACK SYSTEM, manufactured by Telediagnostic Systems, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K071661 · Telediagnostic Systems, Inc. · Neurology device
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Sep 2007
Decision
78d
Days
Class 2
Risk

K071661 is an FDA 510(k) clearance for the ALPHAONE BIOFEEDBACK SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Telediagnostic Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 5, 2007 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Telediagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K071661

510(k) Number K071661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2007
Decision Date September 05, 2007
Days to Decision 78 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 148d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 43
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K071661.
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