Cleared Traditional

K941342 - PAIN DOC

K941342 is the FDA 510(k) clearance for PAIN DOC by Regulatory & Marketing Services, Inc.. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 598-day FDA review.

K941342 · Regulatory & Marketing Services, Inc. · Neurology device
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Oct 1995
Decision
598d
Days
Class 2
Risk

K941342 is an FDA 510(k) clearance for the PAIN DOC. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Florida, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 598 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Regulatory & Marketing Services, Inc. devices

Submission Details

510(k) Number K941342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date October 13, 1995
Days to Decision 598 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
450d slower than avg
Panel avg: 148d · This submission: 598d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

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