Cleared Traditional

E-READER (K970436) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970436 · Natural Herbal Products, Inc. · Neurology device
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Aug 1997
Decision
191d
Days
Class 2
Risk

K970436 is an FDA 510(k) clearance for the E-READER. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Natural Herbal Products, Inc. (Naples, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 191 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1540 - 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 Natural Herbal Products, Inc. devices

Submission Details

510(k) Number K970436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1997
Decision Date August 15, 1997
Days to Decision 191 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
43d slower than avg
Panel avg: 148d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZO Device, Galvanic Skin Response Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1540
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.