Cleared Traditional

K071878 - DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB

K071878 is an FDA 510(k) clearance for DELTA SCANNER, manufactured by Med-Lectric Corporation. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K071878 · Med-Lectric Corporation · Neurology device
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Dec 2007
Decision
154d
Days
Class 2
Risk

K071878 is an FDA 510(k) clearance for the DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Med-Lectric Corporation (Kemah, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 154 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 Med-Lectric Corporation devices

FDA 510(k) Submission Details - K071878

510(k) Number K071878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2007
Decision Date December 07, 2007
Days to Decision 154 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 148d · This submission: 154d
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 197
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K071878.
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