Cleared Traditional

K990766 - CERSR ELECTROMYOGRAPHY SYSTEM

K990766 is an FDA 510(k) clearance for CERSR ELECTROMYOGRAPHY SYSTEM, manufactured by Paraspinal Diagnostic Corp.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K990766 · Paraspinal Diagnostic Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
172d
Days
Class 2
Risk

K990766 is an FDA 510(k) clearance for the CERSR ELECTROMYOGRAPHY SYSTEM. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Paraspinal Diagnostic Corp. (Rockville, US). The FDA issued a Cleared decision on August 27, 1999 after a review of 172 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 Paraspinal Diagnostic Corp. devices

FDA 510(k) Submission Details - K990766

510(k) Number K990766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date August 27, 1999
Days to Decision 172 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 148d · This submission: 172d
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 30
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K990766.
NIM-PRS
K024316 · Medtronic Xomed, Inc. · Jan 2003
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590 · Nihon Kohden America, Inc. · Jun 2001
JE 2000
K993878 · Jack'S Electrodes · Feb 2000
SYNERGY IOM SYSTEM
K984052 · Oxford Instruments Medical Systems · May 1999
TOENNIES NEUROSCREEN SYSTEM
K972419 · Erich Jaeger, Inc. · Apr 1998
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K974385 · Motion Lab Systems, Inc. · Feb 1998