Product code IMG— Physical Medicine
FORTE US
- Classification name
- Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Device class
- Class 2
- Regulation
- 21 CFR 890.5860
- Advisory panel
- Physical Medicine
- Total cleared
- 55
- First cleared
- Most recent
Market context for product code IMG
FDA has cleared devices under product code IMG between 1977 and 2025, filed by 25 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2016
- 2015
- 2012
- 2011
- 2010
- 2007
- 2005
- 2004
- 2003
- 2002
- 2000
- 1999
- 1998
- 1995
Top applicants under product code IMG
Recent clearances under product code IMG
- K244041 — Ultrasound Therapy Workstation (XMS-UET2)
- K153559 — OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
- K150353 — BTL-4000
- K150436 — ComboRehab
- K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICE
- K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
- K102524 — FUTURA
- K111482 — SONICATOR PLUS 920
- K102190 — WINSTIM
- K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE
- K071137 — SONICATOR PLUS 940, MODEL ME940
- K063728 — TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
- K063135 — SONIC-STIM
- K052340 — DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
- K040285 — VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER
- K040121 — DERMAWAVE 5000 COMBI MAX SYSTEM
- K031077 — VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
- K030880 — VECTORSONIC, MODEL VU-270
- K023050 — RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
- K020119 — VECTORSONIC, MODEL VU-200
- K001166 — ULTRA V THERAPEUTIC ULTRASOUND
- K982317 — VECTRA COMBO
- K982830 — FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
- K953614 — FORTE
- K951746 — FORTE CB
- K943469 — SONICATOR 730
- K941561 — FORTE US
- K935728 — DYNATRON 150
- K940180 — FORTE US
- K934287 — DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR
- K934846 — SONICATOR 716
- K935271 — THERAPEUTIC ULTRASOUND AND STIMULATOR
- K934845 — SONICATOR 715
- K932937 — DYNATRON 800
- K922036 — SONOPULS 591
- K921436 — SONICATOR PLUS
- K921952 — ULTRA III
- K920939 — DYNATRON 300 ULRASOUND
- K923797 — MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED
- K911733 — INTELECT, MODEL 245
- K902860 — INTELECT 170
- K902875 — INTELECT 750 MP
- K900189 — CURAPULS 403 DIATHERMY UNIT
- K895690 — ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
- K883893 — OMNISOUND(TM) 3000
- K872909 — SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION
- K872394 — SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
- K871647 — STIMULATOR, ULTRASOUND AND MUSCLE
- K861837 — FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
- K844217 — RICH-MAR DELTA 330 HV
- K843351 — OMNISTIM II COMBIN. THERAPY SYS
- K813594 — INTELECT MODEL 700
- K810526 — RICH-MAR HV II SELECT-A-PULSE
- K772287 — MUSCLE STIMULATOR
- K771157 — RM VI-HV
Data sourced from openFDA. This site is unofficial and independent of the FDA.