Home / Device Classification / IMG

IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Class II

FDA Device Classification

Classification Details

Product Code
IMG
Device Class
Class II
Regulation Number
890.5860
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K244041xemis medical technology (shenzhen) coUltrasound Therapy Workstation (XMS-UET2)October 7, 2025
K153559accelerated care plus (acp)OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SyAugust 26, 2016
K150353btl industriesBTL-4000November 13, 2015
K150436shenzhen dongdixin technology coComboRehabNovember 13, 2015
K120217shenzhen dongdixin technology coSONICSTIMU COMBO THERAPEUTIC DEVICENovember 21, 2012
K121059zimmer medizinsystemsSOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMAugust 7, 2012
K102524oliver wenker, m.d., m.b.aFUTURANovember 3, 2011
K111482mettler electronicsSONICATOR PLUS 920August 25, 2011
K102190johari digital healthcareWINSTIMMarch 17, 2011
K092627shenzhen dongdixin technology coCT2011 SONICSTIMU PAIN RELIEF DEVICEJanuary 14, 2010
K071137mettler electronicsSONICATOR PLUS 940, MODEL ME940August 1, 2007
K063728alfa tech medical systemsTNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEMApril 4, 2007
K063135naimcoSONIC-STIMFebruary 5, 2007
K052340alfa tech medical systemsDU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEMDecember 9, 2005
K040285chattanooga groupVECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTApril 12, 2004
K040121dermawaveDERMAWAVE 5000 COMBI MAX SYSTEMMarch 17, 2004
K031077chattanooga groupVECTRA EPR SYSTEM AND INTELECT EPR SYSTEMDecember 11, 2003
K030880metron medical australia, ptyVECTORSONIC, MODEL VU-270April 18, 2003
K023050reliant technologiesRELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRAFebruary 14, 2003
K020119metron medical australia, ptyVECTORSONIC, MODEL VU-200July 22, 2002