Cleared Traditional

MEGAPULSE II (K973732) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973732 · Pti · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Pti devices

Submission Details

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
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K973732.
ViVY
K250376 · Viatherm Therapeutics, LLC · Nov 2025
Curapuls 670
K243112 · Enraf-Nonius, B.V. · Jun 2025
Reprieve by RegenesisTM
K223620 · Regenesis Biomedical, Inc. · May 2023
BTL-703
K182363 · BTL Industries, Inc. · Jan 2019
ViaTherm BOOST
K173300 · Viatherm Therapeutics, LLC · May 2018