Cleared Traditional

K071866 - NTRAINER SYSTEM

K071866 is an FDA 510(k) clearance for NTRAINER SYSTEM, manufactured by Kcbiomedix, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K071866 · Kcbiomedix, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
210d
Days
Class 2
Risk

K071866 is an FDA 510(k) clearance for the NTRAINER SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Kcbiomedix, Inc. (Lees Summit, US). The FDA issued a Cleared decision on February 1, 2008 after a review of 210 days - an extended review 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: 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 - K071866

510(k) Number K071866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2007
Decision Date February 01, 2008
Days to Decision 210 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
61d slower than avg
Panel avg: 149d · This submission: 210d
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 104
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K071866.
EMG SYSTEM
K111687 · Myotronics-Noromed, Inc. · Sep 2011
GRINDCARE
K092675 · Medotech A/S · Mar 2010
EEG NEUROAMP, MODEL CS10137
K073557 · Corscience GmbH & Co. KG · Feb 2008
ALPHAONE BIOFEEDBACK SYSTEM
K071661 · Telediagnostic Systems, Inc. · Sep 2007
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
RESPERATE
K020399 · Intercure , Ltd. · Jul 2002
K071866 · NTRAINER SYSTEM
Download PDF FDA Summary Kcbiomedix, Inc.