FDA.reportPublic FDA data

510(k) K964083

Device
Ultratherm (908)
Applicant
SIE-MED, INC.
510(k) number
K964083
Product code
IMJ
Decision
Substantially Equivalent (SESE)
Decision date
1997-04-03
Date received
1996-10-11
Regulation
890.5290
Classification name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHARLES H KYPER
Address
11902 Simpson Rd. Clarksville MD US 21029 21029

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IMJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250376ViVYViatherm Therapeutics, LLC2025-11-05
K243112Curapuls 670Enraf-Nonius, B.V.2025-06-25
K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.2023-05-24
K182363BTL-703BTL Industries, Inc.2019-01-24
K173300ViaTherm BOOSTViatherm Therapeutics, LLC2018-05-01
K162240ProMedTek Model C1400 Shortwave Diathermy DevicePromedtek, Inc.2016-11-17
K161862ThermoProZimmer Medizinsysteme GmbH2016-11-14
K153456Megapulse III Shortwave DiathermyAccelerated Care Plus2016-06-14
K131926THERMOPULSEIbramed Equipamentos Medicos2014-07-24
K131899SW-THERMShenzhen Dongdixin Technology Co., Ltd.2014-03-14
K121123BIOFUSIONARY BEBERocky Mountain Biosystems, Inc.2014-03-10
K120093BTL ELITEBTL Industries, Inc.2012-10-05
K083433INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601Chattanooga Group2009-03-18
K042554AUTO THERM 390, MODEL ME 390Mettler Electronics Corp.2004-10-08
K030382SELITHERM, MODEL C100Selicor, Inc.2003-04-01