Cleared Traditional

K962243 - VASOTHERM

K962243 is an FDA 510(k) clearance for VASOTHERM, manufactured by Ehti Medical Corp.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K962243 · Ehti Medical Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
255d
Days
Class 2
Risk

K962243 is an FDA 510(k) clearance for the VASOTHERM. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Ehti Medical Corp. (San Antonio, US). The FDA issued a Cleared decision on February 21, 1997 after a review of 255 days - an extended review cycle.

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 - K962243

510(k) Number K962243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1996
Decision Date February 21, 1997
Days to Decision 255 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
139d slower than avg
Panel avg: 116d · This submission: 255d
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 K962243.
SELICOR, MODELS A100 & D100
K020227 · Selicor, Inc. · Jul 2002
MEGAPULSE II
K973732 · Pti · Jan 1998
ULTRATHERM (908)
K964083 · Sie-Med, Inc. · Apr 1997
THEE THERMASTIM
K962703 · Ehti Medical Corp. · Feb 1997
MAGNATHERM MODEL 1000 SS
K934151 · Intl. Medical Electronics , Ltd. · Feb 1995
TRU-SOUND ULTRASOUND THERAPY UNIT
K871633 · Tru-Trac Therapy Products, Inc. · May 1987
K962243 · VASOTHERM
Download PDF Ehti Medical Corp.