Cleared Traditional

K020803 - CEFAR MEDICAL AB CEFAR PRIMO

K020803 is an FDA 510(k) clearance for CEFAR MEDICAL AB CEFAR PRIMO, manufactured by Cefar Medical AB. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020803 · Cefar Medical AB · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
90d
Days
Class 2
Risk

K020803 is an FDA 510(k) clearance for the CEFAR MEDICAL AB CEFAR PRIMO. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cefar Medical AB (Minneapolis,, US). The FDA issued a Cleared decision on June 10, 2002 after a review of 90 days - within the typical 510(k) review window.

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 - K020803

510(k) Number K020803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date June 10, 2002
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 589
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K020803.
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APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · Apex Medical Corp. · Jun 2002
ULTIMA TENS XL-A1
K020846 · Tenscare, Ltd. · May 2002
SANIDAD HEALTH-UP TENS MP-73725
K014126 · Roc Chinese-European Industrial Research Society · May 2002
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
K021359 · Well-Life Healthcare, Inc. · Apr 2002
K020803 · CEFAR MEDICAL AB CEFAR PRIMO
Download PDF FDA Summary Cefar Medical AB