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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 116d · 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 Consultant

Underwriters Laboratories, Inc.
JEREMI PECK

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 490
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K041146.
MENTAMOVE
K040849 · Cole & Associates · Oct 2004
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
K032954 · Danmeter A/S · Aug 2004
BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004
TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR
K031310 · Tai Sheng Electrical Machinery Co., Ltd. · Apr 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306 · Biomedical Life Systems, Inc. · Mar 2004
AUTOMOVE, MODEL AM800
K032955 · Danmeter A/S · Dec 2003

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K041146 · CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
Download PDF Control Solutions, In…