Cleared Traditional

K813501 - TRANSCUTANEOUS ELEC. NERVE STIMULATOR

K813501 is an FDA 510(k) clearance for TRANSCUTANEOUS ELEC. NERVE STIMULATOR, manufactured by Empi. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K813501 · Empi · Neurology device
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Dec 1981
Decision
15d
Days
Class 2
Risk

K813501 is an FDA 510(k) clearance for the TRANSCUTANEOUS ELEC. NERVE STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Empi (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K813501

510(k) Number K813501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1981
Decision Date December 29, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 149d · This submission: 15d
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 557
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K813501.
EMOTENS
K813569 · Electro Medica Office · Feb 1982
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K812612 · Edu Kit , Ltd. · Feb 1982
10D (TENS DEVICE)
K813283 · Staodynamics, Inc. · Feb 1982
BIO-STIMULATOR, MODEL 400
K813100 · Med-Western Electronics, Inc. · Nov 1981
HEALTH-UP
K812432 · Wfx Industries, Inc. · Nov 1981
NEUROMED SELECTRA #7720
K812704 · Medtronic Vascular · Oct 1981
K813501 · TRANSCUTANEOUS ELEC. NERVE STIMULATOR
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