Cleared Traditional

K864368 - SCHULDT* PLUS 8 T.E.N.S. DEVICE

K864368 is an FDA 510(k) clearance for SCHULDT* PLUS 8 T.E.N.S. DEVICE, manufactured by Schuldt Laboratories, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K864368

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.

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 292
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K864368.
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
ULTRAPAC II SD (TM)
K862337 · Medical Devices, Inc. · Aug 1986