Cleared Traditional

K083202 - COMBOCARE 2000

K083202 is an FDA 510(k) clearance for COMBOCARE 2000, manufactured by Xanacare Technologies, LLC. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K083202 · Xanacare Technologies, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
46d
Days
Class 2
Risk

K083202 is an FDA 510(k) clearance for the COMBOCARE 2000. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Xanacare Technologies, LLC (Golden, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 46 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 - K083202

510(k) Number K083202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2008
Decision Date December 15, 2008
Days to Decision 46 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
103d faster than avg
Panel avg: 149d · This submission: 46d
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 383
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K083202.
TENSCARE ITOUCH MODEL(S) EASY AND PLUS
K082377 · Tenscare, Ltd. · Feb 2009
TENS-EMS-14
K083030 · Emsi · Feb 2009
ULTIMA FIVE
K083494 · Pain Management Technologies · Jan 2009
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · Bio-Medical Research, Ltd. · Nov 2008
TENS/EMS COMBO, EMS, TENS
K082514 · Medihightec Medical Co., Ltd. · Oct 2008
EA STIMULATOR
K080221 · Helio Medical Supplies, Inc. · Sep 2008