Cleared Abbreviated

CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES (K070807) - FDA 510(k) Clearance

Also marketed or referenced as:
TENS ELECTRODES

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K070807 · Pepin Mfg., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
58d
Days
Class 2
Risk

K070807 is an FDA 510(k) clearance for the CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Pepin Mfg., Inc. (Stoughton, US). The FDA issued a Cleared decision on May 23, 2007 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pepin Mfg., Inc. devices

Submission Details

510(k) Number K070807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date May 23, 2007
Days to Decision 58 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 148d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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.

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