IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Class II
FDA product code IMG covers "Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat", a Class II medical device regulated under 21 CFR 890.5860. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K244041 | xemis medical technology (shenzhen) co | Ultrasound Therapy Workstation (XMS-UET2) | October 7, 2025 |
| K153559 | accelerated care plus (acp) | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy Sy | August 26, 2016 |
| K150353 | btl industries | BTL-4000 | November 13, 2015 |
| K150436 | shenzhen dongdixin technology co | ComboRehab | November 13, 2015 |
| K120217 | shenzhen dongdixin technology co | SONICSTIMU COMBO THERAPEUTIC DEVICE | November 21, 2012 |
| K121059 | zimmer medizinsystems | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM | August 7, 2012 |
| K102524 | oliver wenker, m.d., m.b.a | FUTURA | November 3, 2011 |
| K111482 | mettler electronics | SONICATOR PLUS 920 | August 25, 2011 |
| K102190 | johari digital healthcare | WINSTIM | March 17, 2011 |
| K092627 | shenzhen dongdixin technology co | CT2011 SONICSTIMU PAIN RELIEF DEVICE | January 14, 2010 |
| K071137 | mettler electronics | SONICATOR PLUS 940, MODEL ME940 | August 1, 2007 |
| K063728 | alfa tech medical systems | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM | April 4, 2007 |
| K063135 | naimco | SONIC-STIM | February 5, 2007 |
| K052340 | alfa tech medical systems | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM | December 9, 2005 |
| K040285 | chattanooga group | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORT | April 12, 2004 |
| K040121 | dermawave | DERMAWAVE 5000 COMBI MAX SYSTEM | March 17, 2004 |
| K031077 | chattanooga group | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | December 11, 2003 |
| K030880 | metron medical australia, pty | VECTORSONIC, MODEL VU-270 | April 18, 2003 |
| K023050 | reliant technologies | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRA | February 14, 2003 |
| K020119 | metron medical australia, pty | VECTORSONIC, MODEL VU-200 | July 22, 2002 |