Cleared Traditional

K944596 - GRAHAM-FIELD ULTRASOUND LOTION

K944596 is an FDA 510(k) clearance for GRAHAM-FIELD ULTRASOUND LOTION, manufactured by Chester Labs, Inc.. The device is a Class 2 Radiology device with product code IMI cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K944596 · Chester Labs, Inc. · Radiology device
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Jun 1995
Decision
261d
Days
Class 2
Risk

K944596 is an FDA 510(k) clearance for the GRAHAM-FIELD ULTRASOUND LOTION. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Chester Labs, Inc. (Erlanger, US). The FDA issued a Cleared decision on June 7, 1995 after a review of 261 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 890.5300 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Chester Labs, Inc. devices

FDA 510(k) Submission Details - K944596

510(k) Number K944596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date June 07, 1995
Days to Decision 261 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 107d · This submission: 261d
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 Radiology devices follow this clearance model.

Regulatory Peers - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 55
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K944596.
CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
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RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995
INTELECT 222 P
K930307 · Chattanooga Group, Inc. · Jul 1993
SONOPULS 590
K920983 · Henley Intl. · Mar 1993