Cleared Traditional

K022433 - NEOGENESYS 2K

K022433 is an FDA 510(k) clearance for NEOGENESYS 2K, manufactured by Sanexas Intl. GmbH. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K022433 · Sanexas Intl. GmbH · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
183d
Days
Class 2
Risk

K022433 is an FDA 510(k) clearance for the NEOGENESYS 2K. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Sanexas Intl. GmbH (Lee'S Summit, US). The FDA issued a Cleared decision on January 24, 2003 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 - K022433

510(k) Number K022433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2002
Decision Date January 24, 2003
Days to Decision 183 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
34d slower than avg
Panel avg: 149d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - LIH Interferential Current Therapy

All 72
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K022433.
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
K032719 · Gemore Technology Co, Ltd. · Dec 2003
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K033358 · Surgitech, Inc. · Nov 2003
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
K024100 · Theratech, Inc. · Feb 2003
CARE IFC PLUS
K020516 · Care Rehab, Inc. · May 2002
MEDSTAR 100 INTERFERENTIAL STIMLATOR
K013082 · Mednet Services, Inc. · Nov 2001
SMARTWAVE IF 2000
K003631 · Newwave Medical, LLC · Aug 2001
K022433 · NEOGENESYS 2K
Download PDF FDA Summary Sanexas Intl. GmbH