Cleared Traditional

K782127 - STIMULATOR, ELECTRICAL NERVE

K782127 is an FDA 510(k) clearance for STIMULATOR, manufactured by Somatronics, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K782127 · Somatronics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1979
Decision
9d
Days
Class 2
Risk

K782127 is an FDA 510(k) clearance for the STIMULATOR, ELECTRICAL NERVE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Somatronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1979 after a review of 9 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 - K782127

510(k) Number K782127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date January 05, 1979
Days to Decision 9 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
140d faster than avg
Panel avg: 149d · This submission: 9d
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 597
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K782127.
STIMULATOR, MODEL 1-600 ELECTRIC NERVR
K782164 · Ipco Corp. · Mar 1979
STIMULATOR, MENTOR 100 NERVE
K790011 · Mentor Corp. · Mar 1979
ELECTREAT MODEL 250 TRANSCUTANEOUS STIM
K790189 · Electreat, Inc. · Feb 1979
STIMULATOR, MODEL 7727
K782075 · Medtronic Vascular · Dec 1978
NEUROPAC ULTRA II
K781829 · Medical Devices, Inc. · Nov 1978
STIMULATOR, E.S.I. NEURO
K781670 · Evolutionary Systems, Inc. · Nov 1978
K782127 · STIMULATOR, ELECTRICAL NERVE
Download PDF Somatronics, Inc.