Cleared Special

K063599 - PORTI 7 PHYSIOLOGICAL AMPLIFIER

K063599 is an FDA 510(k) clearance for PORTI 7 PHYSIOLOGICAL AMPLIFIER, manufactured by Tms International BV. The device is a Class 2 Neurology device with product code GWL cleared through the Special 510(k) pathway after a 108-day FDA review.

K063599 · Tms International BV · Neurology device
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Mar 2007
Decision
108d
Days
Class 2
Risk

K063599 is an FDA 510(k) clearance for the PORTI 7 PHYSIOLOGICAL AMPLIFIER. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Tms International BV (Evergreen, US). The FDA issued a Cleared decision on March 22, 2007 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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. Standard predicate reliance. 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 - K063599

510(k) Number K063599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2006
Decision Date March 22, 2007
Days to Decision 108 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 149d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 51
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K063599.
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
K092699 · Neurotronics, Inc. · Mar 2010
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
K090957 · I2s Micro Implantable Systems, LLC · May 2009
NEUROMETRIX BIOAMPLIFIER
K083322 · Neurometrix, Inc. · May 2009
REFA, PHYSIOLOGICAL AMPLIFIER
K060374 · Tms International BV · May 2006
G.USBAMP
K060803 · G.Tec Medical Engineering GmbH · May 2006
BE PLUS / AURA-LTM64 AMPLIFIER
K053606 · Eb Neuro S.P.A. · Jan 2006
K063599 · PORTI 7 PHYSIOLOGICAL AMPLIFIER
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