Cleared Traditional

K850855 - TENS GB1001 DEVICE

K850855 is an FDA 510(k) clearance for TENS GB1001 DEVICE, manufactured by Medicon, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K850855 · Medicon, Inc. · Neurology device
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Jan 1986
Decision
314d
Days
Class 2
Risk

K850855 is an FDA 510(k) clearance for the TENS GB1001 DEVICE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medicon, Inc. (Norwalk, US). The FDA issued a Cleared decision on January 9, 1986 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medicon, Inc. devices

FDA 510(k) Submission Details - K850855

510(k) Number K850855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date January 09, 1986
Days to Decision 314 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 148d · This submission: 314d
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 251
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K850855.
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K853992 · Valley Forge Scientific Corp. · Feb 1986
MINIPAC PERSONAL TOUCH (TM)
K854761 · Medical Devices, Inc. · Feb 1986
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