Cleared Traditional

K844680 - CYBERTENS

K844680 is the FDA 510(k) clearance for CYBERTENS by Pori Associates, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K844680 · Pori Associates, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
126d
Days
Class 2
Risk

K844680 is an FDA 510(k) clearance for the CYBERTENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Pori Associates, Inc. (Dacifica, US). The FDA issued a Cleared decision on April 5, 1985 after a review of 126 days - within the typical 510(k) review window.

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 Pori Associates, Inc. devices

Submission Details

510(k) Number K844680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date April 05, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
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 137
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K844680.
TENSMED II
K851063 · Intermedics, Inc. · Jun 1985
ELECTRO-NERVE STIMULATOR DISCO B9 TENS
K851191 · Biomedical Life Systems, Inc. · May 1985
ELECTRO-NERVE STIMULATOR B4/B400
K851185 · Biomedical Life Systems, Inc. · May 1985
INTERCEPTOR, 662-01
K844279 · Intermedics, Inc. · Jan 1985
ELECTRO-NERVE STIMULATOR B5/SK700B
K844076 · Biomedical Life Systems, Inc. · Jan 1985
STIMTECH SD CLINICIAN 6090 #78-8055
K844212 · Codman & Shurtleff, Inc. · Jan 1985