Cleared Traditional

K850860 - AXON II BRAND OF DUAL CHANNEL TENS

K850860 is the FDA 510(k) clearance for AXON II BRAND OF DUAL CHANNEL TENS by Cassandra Electronics Corp.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K850860 · Cassandra Electronics Corp. · Neurology device
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May 1985
Decision
91d
Days
Class 2
Risk

K850860 is an FDA 510(k) clearance for the AXON II BRAND OF DUAL CHANNEL TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cassandra Electronics Corp. (Minneapolis, US). The FDA issued a Cleared decision on May 31, 1985 after a review of 91 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 Cassandra Electronics Corp. devices

Submission Details

510(k) Number K850860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date May 31, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 148d · This submission: 91d
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 136
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K850860.
MINIPAC (TM)
K854317 · Medical Devices, Inc. · Jan 1986
SYS STIM 206 MODEL ME206
K851735 · Mettler Electronics Corp. · Nov 1985
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