Cleared Traditional

K864114 - TENS DEVICE FOR RELIEF OF CHRONIC PAIN

K864114 is an FDA 510(k) clearance for TENS DEVICE FOR RELIEF OF CHRONIC PAIN, manufactured by Futuremed Div. of Future Impex Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K864114 · Futuremed Div. of Future Impex Corp. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 1987
Decision
162d
Days
Class 2
Risk

K864114 is an FDA 510(k) clearance for the TENS DEVICE FOR RELIEF OF CHRONIC PAIN. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Futuremed Div. of Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on April 1, 1987 after a review of 162 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 Futuremed Div. of Future Impex Corp. devices

FDA 510(k) Submission Details - K864114

510(k) Number K864114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date April 01, 1987
Days to Decision 162 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 148d · This submission: 162d
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 174
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K864114.
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
K871126 · Biomedical Life Systems, Inc. · Jun 1987
OMEGA T100
K870666 · Henley Intl. · Apr 1987
OMEGA T200
K870667 · Henley Intl. · 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