Cleared Traditional

K844994 - THE MEHESZ STIMULATING SYSTEM

K844994 is the FDA 510(k) clearance for THE MEHESZ STIMULATING SYSTEM by Campden Medical , Ltd.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K844994 · Campden Medical , Ltd. · Neurology device
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Mar 1985
Decision
70d
Days
Class 2
Risk

K844994 is an FDA 510(k) clearance for the THE MEHESZ STIMULATING SYSTEM. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Campden Medical , Ltd. (London - W8 7th, GB). The FDA issued a Cleared decision on March 6, 1985 after a review of 70 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 Campden Medical , Ltd. devices

Submission Details

510(k) Number K844994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date March 06, 1985
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 148d · This submission: 70d
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 K844994.
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