Cleared Traditional

K964622 - MEDI-DX 7000

K964622 is an FDA 510(k) clearance for MEDI-DX 7000, manufactured by Neuro-Diagnostic Assoc.. The device is a Class 1 Neurology device with product code LLN cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K964622 · Neuro-Diagnostic Assoc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
378d
Days
Class 1
Risk

K964622 is an FDA 510(k) clearance for the MEDI-DX 7000. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Neuro-Diagnostic Assoc. (Laguna Beach, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - 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.

FDA 510(k) Submission Details - K964622

510(k) Number K964622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1996
Decision Date December 01, 1997
Days to Decision 378 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 149d · This submission: 378d
Pathway characteristics
Predicate-based equivalence.

LLN Device Classification - Class 1, General Controls

Product Code LLN Device, Vibration Threshold Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LLN Device, Vibration Threshold Measurement

All 11
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K964622 · MEDI-DX 7000
Download PDF FDA Summary Neuro-Diagnostic Asso…