Cleared Traditional

K903814 - NEUROMED TS8 TEST STIMULATOR

K903814 is an FDA 510(k) clearance for NEUROMED TS8 TEST STIMULATOR, manufactured by Neuromed, Inc.. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K903814 · Neuromed, Inc. · Neurology device
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Jan 1991
Decision
149d
Days
Class 2
Risk

K903814 is an FDA 510(k) clearance for the NEUROMED TS8 TEST STIMULATOR. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Neuromed, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 149 days - within the typical 510(k) review window.

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: 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 Neuromed, Inc. devices

FDA 510(k) Submission Details - K903814

510(k) Number K903814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date January 16, 1991
Days to Decision 149 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 148d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

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)

All 118
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K903814.
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