Cleared Traditional

K945509 - FX-2 NMS (2CHANNEL TABLE MODEL)

K945509 is an FDA 510(k) clearance for FX-2 NMS (2CHANNEL TABLE MODEL), manufactured by Fx-2. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K945509 · Fx-2 · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
174d
Days
Class 2
Risk

K945509 is an FDA 510(k) clearance for the FX-2 NMS (2CHANNEL TABLE MODEL). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Fx-2 (Guilford, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 174 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Fx-2 devices

FDA 510(k) Submission Details - K945509

510(k) Number K945509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date May 02, 1995
Days to Decision 174 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 115d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K945509.
BX-200 SC
K943185 · Bloomex International, Inc. · Aug 1995
CHAL-2500
K946186 · Hogan & Hartson · Aug 1995
DYNATRON 250
K944935 · Dynatronics Corp. · Jun 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916 · Biomedical Life Systems, Inc. · Jan 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992