Cleared Traditional

K102610 - FOCUS EMG DEVICE

K102610 is an FDA 510(k) clearance for FOCUS EMG DEVICE, manufactured by Teleemg, LLC USA. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K102610 · Teleemg, LLC USA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
175d
Days
Class 2
Risk

K102610 is an FDA 510(k) clearance for the FOCUS EMG DEVICE. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Teleemg, LLC USA (Woburn, US). The FDA issued a Cleared decision on March 4, 2011 after a review of 175 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.

View all Teleemg, LLC USA devices

FDA 510(k) Submission Details - K102610

510(k) Number K102610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2010
Decision Date March 04, 2011
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - IKN Electromyograph, Diagnostic

All 43
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