Cleared Traditional

K850855 - TENS GB1001 DEVICE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K850855.
actiTENS mini
K252767 · Sublimed · Jan 2026
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K252236 · N & C Holdings, LLC · Aug 2025
Unipro (K-UNIPRO-US)
K232441 · Tenscare, Ltd. · Aug 2024
TENSWave
K241228 · Zynex Medical Officer · Aug 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · Oriental Inspiration Limited · Apr 2024
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jan 2023