Cleared Traditional

K993420 - CONTROL SOLUTIONS INC, MODEL CS3101

K993420 is an FDA 510(k) clearance for CONTROL SOLUTIONS INC, 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 281-day FDA review.

K993420 · Control Solutions, Inc. · Physical Medicine device
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Jul 2000
Decision
281d
Days
Class 2
Risk

K993420 is an FDA 510(k) clearance for the CONTROL SOLUTIONS INC, MODEL CS3101. 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 July 19, 2000 after a review of 281 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 Control Solutions, Inc. devices

FDA 510(k) Submission Details - K993420

510(k) Number K993420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date July 19, 2000
Days to Decision 281 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 115d · This submission: 281d
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 230
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K993420.
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RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · Rich-Mar Corp. · Aug 2000
HMS NEUROMUSCULAR STIMULATOR
K994062 · Home Medical Services, Inc. · Apr 2000
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K994065 · Home Wellness West · Apr 2000
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
K993821 · Metron Medical Australia, Pty, Ltd. · Dec 1999