Cleared Traditional

K883188 - T.E.N.S. UNIT SIGMA & TX-3

K883188 is an FDA 510(k) clearance for T.E.N.S. UNIT SIGMA & TX-3, manufactured by Diamond Medical Equipment, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K883188 · Diamond Medical Equipment, Inc. · Neurology device
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Dec 1988
Decision
141d
Days
Class 2
Risk

K883188 is an FDA 510(k) clearance for the T.E.N.S. UNIT SIGMA & TX-3. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Diamond Medical Equipment, Inc. (Jamaica, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 141 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 Diamond Medical Equipment, Inc. devices

FDA 510(k) Submission Details - K883188

510(k) Number K883188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date December 16, 1988
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 148d · This submission: 141d
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 291
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K883188.
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