Cleared Traditional

K862454 - AGAR 7K TENS INSTRUMENT

K862454 is an FDA 510(k) clearance for AGAR 7K TENS INSTRUMENT, manufactured by Solcoor, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K862454 · Solcoor, Inc. · Neurology device
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Mar 1987
Decision
271d
Days
Class 2
Risk

K862454 is an FDA 510(k) clearance for the AGAR 7K TENS INSTRUMENT. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Solcoor, Inc. (Vienna, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 271 days - an extended review 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: 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

FDA 510(k) Submission Details - K862454

510(k) Number K862454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1986
Decision Date March 25, 1987
Days to Decision 271 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 148d · This submission: 271d
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 286
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K862454.
OMEGA T200
K870667 · Henley Intl. · Apr 1987
TENS DEVICE FOR RELIEF OF CHRONIC PAIN
K864114 · Futuremed Div. of Future Impex Corp. · Apr 1987
EMPI LOGIX MODEL 712 NMS, TENS
K870168 · Empi · Apr 1987
BACPAC (TM), MODEL 6500
K864968 · Medical Devices, Inc. · Mar 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · Medtronic Vascular · Feb 1987
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K863469 · Cordis Corp. · Feb 1987