Cleared Traditional

K953614 - FORTE

K953614 is an FDA 510(k) clearance for FORTE, 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 85-day FDA review.

K953614 · Chattanooga Group, Inc. · Physical Medicine device
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Oct 1995
Decision
85d
Days
Class 2
Risk

K953614 is an FDA 510(k) clearance for the FORTE. 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 October 27, 1995 after a review of 85 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 - K953614

510(k) Number K953614 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 03, 1995
Decision Date October 27, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 K953614.
ULTRA V THERAPEUTIC ULTRASOUND
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K982317 · Chattanooga Group, Inc. · Feb 1999
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FORTE CB
K951746 · Chattanooga Group, Inc. · Jun 1995
SONICATOR 730
K943469 · Mettler Electronics Corp. · Aug 1994
FORTE US
K941561 · Chattanooga Group, Inc. · Jun 1994