Cleared Traditional

SCHULDT* PLUS 8 T.E.N.S. DEVICE (K864368) - FDA 510(k) Clearance

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

K864368 · Schuldt Laboratories, Inc. · Neurology device
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Feb 1987
Decision
113d
Days
Class 2
Risk

K864368 is an FDA 510(k) clearance for the SCHULDT* PLUS 8 T.E.N.S. DEVICE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Schuldt Laboratories, Inc. (Canada V1y 2g4, CA). The FDA issued a Cleared decision on February 26, 1987 after a review of 113 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 Schuldt Laboratories, Inc. devices

Submission Details

510(k) Number K864368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date February 26, 1987
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
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 39
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K864368.
DYNEX IIIB, MODEL 89002026
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TENZCARE STIMULATOR 6890
K891992 · 3M Company · Oct 1989
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