Cleared Traditional

K922839 - MID-CANADA MEDICAL

K922839 is an FDA 510(k) clearance for MID-CANADA MEDICAL, manufactured by Mid-Canada Medical. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K922839 · Mid-Canada Medical · Physical Medicine device
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Jul 1993
Decision
385d
Days
Class 2
Risk

K922839 is an FDA 510(k) clearance for the MID-CANADA MEDICAL. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Mid-Canada Medical (Mississauga, Ontario, CA). The FDA issued a Cleared decision on July 2, 1993 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mid-Canada Medical devices

FDA 510(k) Submission Details - K922839

510(k) Number K922839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date July 02, 1993
Days to Decision 385 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 115d · This submission: 385d
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 64
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K922839.
MATRIX MICROSON 410
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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
ULTRA SX
K923076 · Excel Tech. , Ltd. · Mar 1993