Cleared Traditional

K041146 - CONTROL SOLUTIONS, INC., MODEL CS3102 HVG

K041146 is an FDA 510(k) clearance for CONTROL SOLUTIONS, manufactured by Control Solutions, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K041146 · Control Solutions, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
36d
Days
Class 2
Risk

K041146 is an FDA 510(k) clearance for the CONTROL SOLUTIONS, INC., MODEL CS3102 HVG. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Control Solutions, Inc. (Naperville, US). The FDA issued a Cleared decision on June 8, 2004 after a review of 36 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Control Solutions, Inc. devices

FDA 510(k) Submission Details - K041146

510(k) Number K041146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date June 08, 2004
Days to Decision 36 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 231
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K041146.
NEUROTECH KNEEHAB
K024258 · Bio-Medical Research, Ltd. · Mar 2005
INFINITY PLUS ELECTROTHERAPY SYSTEM
K041920 · Empi · Jan 2005
BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306 · Biomedical Life Systems, Inc. · Mar 2004
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544 · Everyway Medical Instruments Co.,Ltd · Dec 2003
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
K033140 · Everyway Medical Instruments Co.,Ltd · Oct 2003