Cleared Traditional

K142666 - Scrambler Therapy MC-5 A Device

K142666 is an FDA 510(k) clearance for Scrambler Therapy MC-5 A Device, manufactured by Delta International Services & Logistics S.R.L. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K142666 · Delta International Services & Logistics S.R.L · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
246d
Days
Class 2
Risk

K142666 is an FDA 510(k) clearance for the Scrambler Therapy MC-5 A Device. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Delta International Services & Logistics S.R.L (Rome, IT). The FDA issued a Cleared decision on May 22, 2015 after a review of 246 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.

View all Delta International Services & Logistics S.R.L devices

FDA 510(k) Submission Details - K142666

510(k) Number K142666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2014
Decision Date May 22, 2015
Days to Decision 246 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
98d slower than avg
Panel avg: 148d · This submission: 246d
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 254
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K142666.
FD TENS 2090, FD TENS 2095
K152676 · Fuji Dynamics , Ltd. · Jan 2016
BiowaveHOME Neuromodulation Pain Therapy Device
K152437 · Biowave Corporation · Sep 2015
Synapse Transcutaneous Electrical Stimulation Device
K143198 · Synapse Electroceutical Limited · May 2015
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
K131513 · Ritm Okb Zao · Jul 2014
CP RELIEF WAND
K133779 · Mid-America Medical Innovations, LLC · May 2014
Best-AV2 Pro-Sport(tm)
K123099 · Avazzia, Inc. · May 2014