Cleared Traditional

K973732 - MEGAPULSE II

K973732 is an FDA 510(k) clearance for MEGAPULSE II, manufactured by Pti. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K973732 · Pti · Physical Medicine device
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Jan 1998
Decision
115d
Days
Class 2
Risk

K973732 is an FDA 510(k) clearance for the MEGAPULSE II. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Pti (Topeka, US). The FDA issued a Cleared decision on January 23, 1998 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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.

FDA 510(k) Submission Details - K973732

510(k) Number K973732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1997
Decision Date January 23, 1998
Days to Decision 115 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
1d faster than avg
Panel avg: 116d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMJ Device Classification - Class 2, Special Controls

Product Code IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 41
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K973732.
SW-180 SHORTWAVE THERAPY UNIT
K022846 · Ito Co., Ltd. · Jan 2003
AUTO*THERM 395, MODEL ME 395
K022458 · Mettler Electronics Corp. · Sep 2002
SELICOR, MODELS A100 & D100
K020227 · Selicor, Inc. · Jul 2002
ULTRATHERM (908)
K964083 · Sie-Med, Inc. · Apr 1997
VASOTHERM
K962243 · Ehti Medical Corp. · Feb 1997
THEE THERMASTIM
K962703 · Ehti Medical Corp. · Feb 1997
K973732 · MEGAPULSE II
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