Cleared Traditional

K813601 - E.W.L. P-TENS MODEL(TENS

K813601 is the FDA 510(k) clearance for E.W.L. P-TENS MODEL(TENS by Electronic Waveform Laboratory, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K813601 · Electronic Waveform Laboratory, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1982
Decision
81d
Days
Class 2
Risk

K813601 is an FDA 510(k) clearance for the E.W.L. P-TENS MODEL(TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Electronic Waveform Laboratory, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1982 after a review of 81 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.

View all Electronic Waveform Laboratory, Inc. devices

Submission Details

510(k) Number K813601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1981
Decision Date March 19, 1982
Days to Decision 81 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 148d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K813601.
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983
WRIGHT CARE
K823497 · Dow Corning Wright · Jan 1983
NEUROMEDICS ORIONS #660-01
K822600 · Intermedics, Inc. · Sep 1982
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
K813501 · Empi · Dec 1981
NEUROMED SELECTRA #7720
K812704 · Medtronic Vascular · Oct 1981
NEUROPAC ULTRA I
K810593 · Medical Devices, Inc. · Mar 1981