Cleared Special

K110048 - CERSR ELECTROMYOGRAPHY SYSTEM

K110048 is an FDA 510(k) clearance for CERSR ELECTROMYOGRAPHY SYSTEM, manufactured by Spinematrix, Inc.. The device is a Class 2 Neurology device with product code IKN cleared through the Special 510(k) pathway after a 20-day FDA review.

K110048 · Spinematrix, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
20d
Days
Class 2
Risk

K110048 is an FDA 510(k) clearance for the CERSR ELECTROMYOGRAPHY SYSTEM. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Spinematrix, Inc. (Philedelphia, US). The FDA issued a Cleared decision on January 26, 2011 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110048

510(k) Number K110048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2011
Decision Date January 26, 2011
Days to Decision 20 days
Submission Type Special
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
129d faster than avg
Panel avg: 149d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 71
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K110048 · CERSR ELECTROMYOGRAPHY SYSTEM
Download PDF FDA Summary Spinematrix, Inc.