Cleared Traditional

K935271 - THERAPEUTIC ULTRASOUND AND STIMULATOR

K935271 is an FDA 510(k) clearance for THERAPEUTIC ULTRASOUND AND STIMULATOR, 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 92-day FDA review.

K935271 · Chattanooga Group, Inc. · Physical Medicine device
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Feb 1994
Decision
92d
Days
Class 2
Risk

K935271 is an FDA 510(k) clearance for the THERAPEUTIC ULTRASOUND AND STIMULATOR. 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 February 2, 1994 after a review of 92 days - within the typical 510(k) review window.

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: 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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K935271

510(k) Number K935271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date February 02, 1994
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
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 K935271.
FORTE US
K941561 · Chattanooga Group, Inc. · Jun 1994
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K940180 · Chattanooga Group, Inc. · Apr 1994
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K921436 · Mettler Electronics Corp. · Apr 1993