Cleared Traditional

K930307 - INTELECT 222 P

K930307 is an FDA 510(k) clearance for INTELECT 222 P, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K930307 · Chattanooga Group, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
162d
Days
Class 2
Risk

K930307 is an FDA 510(k) clearance for the INTELECT 222 P. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 162 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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 - K930307

510(k) Number K930307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date July 02, 1993
Days to Decision 162 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
47d slower than avg
Panel avg: 115d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 31
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K930307.
FORTE, MODEL CPS ULTRASOUND
K982829 · Chattanooga Group, Inc. · Nov 1998
INTELECT LEGEND ULTRASOUND
K973024 · Chattanooga Group, Inc. · Nov 1997
RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995
SONOPULS 590
K920983 · Henley Intl. · Mar 1993
ULTRA SX
K923076 · Excel Tech. , Ltd. · Mar 1993
RICH-MAR MODEL 510 ULTRASOUND
K915557 · Rich-Mar Corp. · Mar 1992