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)
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.

View all Surgitech, Inc. devices

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
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 148d · 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 41
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