Cleared Traditional

K941561 - FORTE US

K941561 is an FDA 510(k) clearance for FORTE US, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K941561 · Chattanooga Group, Inc. · Physical Medicine device
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Jun 1994
Decision
80d
Days
Class 2
Risk

K941561 is an FDA 510(k) clearance for the FORTE US. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on June 20, 1994 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K941561

510(k) Number K941561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date June 20, 1994
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMG Device Classification - Class 2, Special Controls

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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 - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 30
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K941561.
FORTE
K953614 · Chattanooga Group, Inc. · Oct 1995
FORTE CB
K951746 · Chattanooga Group, Inc. · Jun 1995
SONICATOR 730
K943469 · Mettler Electronics Corp. · Aug 1994
FORTE US
K940180 · Chattanooga Group, Inc. · Apr 1994
SONICATOR 716
K934846 · Mettler Electronics Corp. · Mar 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935271 · Chattanooga Group, Inc. · Feb 1994