Cleared Traditional

K843221 - MEGASON MODEL 150

K843221 is an FDA 510(k) clearance for MEGASON MODEL 150, manufactured by Birtcher Corp.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K843221 · Birtcher Corp. · Physical Medicine device
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Aug 1984
Decision
8d
Days
Class 2
Risk

K843221 is an FDA 510(k) clearance for the MEGASON MODEL 150. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Birtcher Corp. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1984 after a review of 8 days - a notably fast clearance 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: 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 Birtcher Corp. devices

FDA 510(k) Submission Details - K843221

510(k) Number K843221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1984
Decision Date August 24, 1984
Days to Decision 8 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
107d faster than avg
Panel avg: 115d · This submission: 8d
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 35
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K843221.
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · Henley Intl. · Jul 1987
SONICATOR 705 MODEL ME 705
K851397 · Mettler Electronics Corp. · Jul 1985
US 610
K844036 · Rich-Mar Corp. · Nov 1984
INTELECT 205 PORTABLE ULTRASOUND UNIT
K841445 · Chattanooga Group, Inc. · May 1984
INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · Chattanooga Group, Inc. · May 1984
INTELECT 210 PORTABLE ULTRASOUND
K841447 · Chattanooga Group, Inc. · May 1984