Cleared Traditional

K010615 - CYCLOTEC AMT CTI TENS DEVICE

K010615 is an FDA 510(k) clearance for CYCLOTEC AMT CTI TENS DEVICE, manufactured by Cyclotec. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K010615 · Cyclotec · Neurology device
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Oct 2001
Decision
225d
Days
Class 2
Risk

K010615 is an FDA 510(k) clearance for the CYCLOTEC AMT CTI TENS DEVICE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cyclotec (Lauderhill, US). The FDA issued a Cleared decision on October 12, 2001 after a review of 225 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 - K010615

510(k) Number K010615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2001
Decision Date October 12, 2001
Days to Decision 225 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 149d · This submission: 225d
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 588
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K010615.
STRESS GUARD, MODEL HERDEV1
K004008 · Herbo Medex International, Inc. · Dec 2001
APEX MEDICAL LCD TENS-VII
K012643 · Apex Medical Corp. · Oct 2001
WINNER CM4 COMBINATION UNIT
K012848 · Rich-Mar Corp. · Oct 2001
PROMAX-XP, TENS AND MICROCURRENT DEVICE
K011017 · Rehabilicare, Inc. · Sep 2001
TENS CARE, MODEL XL-Y3
K011543 · Tenscare, Ltd. · Aug 2001
ACCU-PULSE TENS UNIT
K010203 · Sadler Electronics · Aug 2001
K010615 · CYCLOTEC AMT CTI TENS DEVICE
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