Cleared Traditional

K123399 - MYOVISION 3.0 WIREFREE SYSTEM

K123399 is an FDA 510(k) clearance for MYOVISION 3.0 WIREFREE SYSTEM, manufactured by Precision Biometrics, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K123399 · Precision Biometrics, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
269d
Days
Class 2
Risk

K123399 is an FDA 510(k) clearance for the MYOVISION 3.0 WIREFREE SYSTEM. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Precision Biometrics, Inc. (Seattle, US). The FDA issued a Cleared decision on August 1, 2013 after a review of 269 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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.

FDA 510(k) Submission Details - K123399

510(k) Number K123399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date August 01, 2013
Days to Decision 269 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 149d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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