Cleared Traditional

K033358 - CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000

K033358 is an FDA 510(k) clearance for CHRONIC PAIN SUPPRESSOR CPS-2000, manufactured by Surgitech, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K033358 · Surgitech, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
25d
Days
Class 2
Risk

K033358 is an FDA 510(k) clearance for the CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Surgitech, Inc. (Oceanside, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 25 days - a notably fast clearance 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: 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 - K033358

510(k) Number K033358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2003
Decision Date November 14, 2003
Days to Decision 25 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
124d faster than avg
Panel avg: 149d · This submission: 25d
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 K033358.
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
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INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
K032719 · Gemore Technology Co, Ltd. · Dec 2003
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
K024100 · Theratech, Inc. · Feb 2003
NEOGENESYS 2K
K022433 · Sanexas Intl. GmbH · Jan 2003
CARE IFC PLUS
K020516 · Care Rehab, Inc. · May 2002
K033358 · CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
Download PDF FDA Summary Surgitech, Inc.