Cleared Traditional

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM (K911911) - FDA 510(k) Clearance

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

K911911 · Medical Design & Manufacturing Corp. · Neurology device
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Mar 1992
Decision
325d
Days
Class 2
Risk

K911911 is an FDA 510(k) clearance for the MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Medical Design & Manufacturing Corp. (Westerville, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K911911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1991
Decision Date March 20, 1992
Days to Decision 325 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
177d slower than avg
Panel avg: 148d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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.