Cleared Traditional

K143198 - Synapse Transcutaneous Electrical Stimulation Device

K143198 is an FDA 510(k) clearance for Synapse Transcutaneous Electrical Stimu..., manufactured by Synapse Electroceutical Limited. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K143198 · Synapse Electroceutical Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
202d
Days
Class 2
Risk

K143198 is an FDA 510(k) clearance for the Synapse Transcutaneous Electrical Stimulation Device. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Synapse Electroceutical Limited (Westerham, GB). The FDA issued a Cleared decision on May 27, 2015 after a review of 202 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 - K143198

510(k) Number K143198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2014
Decision Date May 27, 2015
Days to Decision 202 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
53d slower than avg
Panel avg: 149d · This submission: 202d
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 Consultant

Martin,Blank & Associates
MARY DADONE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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K143198 · Synapse Transcutaneous Electrical Stimulation Device
Download PDF FDA Summary Synapse Electroceutic…