Cleared Traditional

K060158 - NET-2000 MICROCURRENT STIMULATOR

K060158 is an FDA 510(k) clearance for NET-2000 MICROCURRENT STIMULATOR, manufactured by Auri-Stem Medical, Inc.. The device is a Class 2 Neurology device with product code QJQ cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K060158 · Auri-Stem Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
266d
Days
Class 2
Risk

K060158 is an FDA 510(k) clearance for the NET-2000 MICROCURRENT STIMULATOR. Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Auri-Stem Medical, Inc. (Boulder, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 266 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5800 - 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 - K060158

510(k) Number K060158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2006
Decision Date October 13, 2006
Days to Decision 266 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
117d slower than avg
Panel avg: 149d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJQ Device Classification - Class 2, Special Controls

Product Code QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5800
Definition To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety
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

Auri-Stim Medical, Inc.
LEWIS WARD

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 - QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety

All 17
Devices cleared under the same product code (QJQ) and FDA review panel - the closest regulatory comparables to K060158.
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K090052 · Johari Digital Healthcare , Ltd. · May 2009
ELEXOMA MEDIC
K070412 · Redplane AG · May 2008
CES ULTRA
K062284 · Neuro-Fitness, LLC · Apr 2007
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
K024377 · Kalaco Scientific, Inc. · Jul 2003
NH-2002
K932050 · New Horizon Health Care · Jun 1995
ALPHA-STIM CS
K903014 · Electromedical Products, Inc. · May 1992
K060158 · NET-2000 MICROCURRENT STIMULATOR
Download PDF FDA Summary Auri-Stem Medical, In…