Cleared Traditional

K770987 - NERVE STIMULATOR

K770987 is the FDA 510(k) clearance for NERVE STIMULATOR by Output, Inc.. It is a Class 2 Neurology device (product code GZI) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K770987 · Output, Inc. · Neurology device
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Jun 1977
Decision
14d
Days
Class 2
Risk

K770987 is an FDA 510(k) clearance for the NERVE STIMULATOR, MOLEL NO. FB-800. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Output, Inc. (Walker, US). The FDA issued a Cleared decision on June 14, 1977 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Output, Inc. devices

Submission Details

510(k) Number K770987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1977
Decision Date June 14, 1977
Days to Decision 14 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 148d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
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.