Cleared Traditional

K932849 - PMI TENS ELECTRODE

K932849 is an FDA 510(k) clearance for PMI TENS ELECTRODE, manufactured by Pepin Mfg., Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K932849 · Pepin Mfg., Inc. · Neurology device
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Jan 1994
Decision
231d
Days
Class 2
Risk

K932849 is an FDA 510(k) clearance for the PMI TENS ELECTRODE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Pepin Mfg., Inc. (Stoughton, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 231 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 - K932849

510(k) Number K932849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1993
Decision Date January 27, 1994
Days to Decision 231 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
82d slower than avg
Panel avg: 149d · This submission: 231d
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 548
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K932849.
EZ GRIP REUSABLE TENS/NMES ELECTRODES
K931108 · Advanced Adhesives · Feb 1994
NEUROMUSCULAR STIMULATOR
K932611 · Myo/Kinetic Systems, Inc. · Jan 1994
PURECARE AT-903 T.E.N.S.
K931715 · Fuching Enterprise Co., Ltd. · Jan 1994
NEUTRALIZER
K932320 · Smith and Nephew Donjoy, Inc. · Oct 1993
COM-TENS (SINGLE MODE)
K931570 · Ems Dist. · Jun 1993
MAXIMA I
K931424 · Staodyne, Inc. · Jun 1993
K932849 · PMI TENS ELECTRODE
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