Cleared Traditional

K861894 - AGAR 9K TENS

K861894 is the FDA 510(k) clearance for AGAR 9K TENS by Solcoor, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K861894 · Solcoor, Inc. · Neurology device
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Sep 1986
Decision
116d
Days
Class 2
Risk

K861894 is an FDA 510(k) clearance for the AGAR 9K TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Solcoor, Inc. (Arlington, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 116 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 Solcoor, Inc. devices

Submission Details

510(k) Number K861894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1986
Decision Date September 09, 1986
Days to Decision 116 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 148d · This submission: 116d
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 49
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K861894.
MEDTENS(TM), MODEL NUMBER 7725
K871722 · Medtronic Vascular · Jul 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · Medtronic Vascular · Feb 1987
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K863469 · Cordis Corp. · Feb 1987
TENSMED II
K851063 · Intermedics, Inc. · Jun 1985
INTERCEPTOR, 662-01
K844279 · Intermedics, Inc. · Jan 1985
STIMTECH SD CLINICIAN 6090 #78-8055
K844212 · Codman & Shurtleff, Inc. · Jan 1985