Cleared Traditional

K880426 - ELECTROSTIMULATOR MODEL 808

K880426 is an FDA 510(k) clearance for ELECTROSTIMULATOR MODEL 808, manufactured by Cornell Enterprises Co., 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.

K880426 · Cornell Enterprises Co., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
231d
Days
Class 2
Risk

K880426 is an FDA 510(k) clearance for the ELECTROSTIMULATOR MODEL 808. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cornell Enterprises Co., Inc. (San Diego, US). The FDA issued a Cleared decision on September 19, 1988 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.

View all Cornell Enterprises Co., Inc. devices

FDA 510(k) Submission Details - K880426

510(k) Number K880426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date September 19, 1988
Days to Decision 231 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 148d · 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 291
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K880426.
MEDIMOD(TM), MODEL 8900
K890705 · Medical Devices, Inc. · Mar 1989
HEPAX (TENS)
K882154 · Avl Scientific Corp. · Sep 1988
EMPI MODEL 727,NMS
K882631 · Empi · Sep 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · Medical Devices, Inc. · Aug 1988
EMPI MODEL 989, TENS
K881114 · Empi · Apr 1988
ULTRAPAC II SX PLUS (TM)
K872657 · Medical Devices, Inc. · Aug 1987