Product code IMI— Physical Medicine
ACCUSONIC ADVANTAGE
- Classification name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device class
- Class 2
- Regulation
- 21 CFR 890.5300
- Advisory panel
- Physical Medicine
- Total cleared
- 89
- First cleared
- Most recent
Market context for product code IMI
FDA has cleared devices under product code IMI between 1978 and 2025, filed by 51 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
- 2023
- 2022
- 2021
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
Top applicants under product code IMI
Recent clearances under product code IMI
- K240788 — Ultrasound Stimulator
- K230472 — Sonopuls 190
- K222098 — ManaSport+
- K210284 — ManaSport
- K202788 — Sonomed IV, Sonomed V
- K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
- K161628 — JAS Pulse(TM) Ultrasonic Therapy
- K160075 — Accent XL
- K161502 — MC1 Plus
- K142976 — UltraTENS
- K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
- K130888 — SONOPULSE/ SONOPULSE III
- K124010 — ACCUSONIC ADVANTAGE
- K120171 — ACCUSONIC ADVANTAGE
- K112520 — US-101L, US-103S
- K091615 — MED CONTOUR
- K090542 — SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
- K062256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
- K053041 — MED SCULPT
- K052934 — DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
- K053546 — SONICATOR 740, MODEL ME 740
- K050410 — HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
- K040798 — HES ULTRASONIC THERAPY APPLIANCE
- K031116 — VECTRA (INTELECT) EPR ULTRASOUND
- K024013 — SUN-RAIN ULTRASONIC THERAPY, SU-100
- K031329 — DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
- K032793 — US-100 PORTABLE ULTRASOUND THERAPY UNIT
- K024307 — DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
- K030878 — ACCOUSONIC, MODEL AS-270
- K030410 — ACCOUSONIC PLUS, MODEL AP-170
- K021483 — RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
- K013192 — SONICATOR PLUS 930, MODEL ME 930
- K010702 — XUB EXTERNAL ULTRASOUND
- K011955 — MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
- K010609 — ACCUSONIC, MODEL AS-260
- K010102 — SONIC MODEL SO-300
- K991613 — SW ULTRASOUND, MODELS 331, 311, 333
- K000084 — ENRAF-NONIUS SONOPULS 190 SYSTEM
- K000593 — SONIC, MODEL SO-100
- K001370 — ACCUSONIC PLUS, MODEL AP-100
- K000604 — NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
- K984199 — EXONIX
- K981449 — SD-956 ULTRASOUND THERAPY
- K982544 — RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
- K982829 — FORTE, MODEL CPS ULTRASOUND
- K973024 — INTELECT LEGEND ULTRASOUND
- K970131 — ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
- K961250 — DYNATRON 125 ULTRASOUND
- K960802 — CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
- K954136 — MATRIX MICROSON 410
- K952536 — SONO 5
- K944596 — GRAHAM-FIELD ULTRASOUND LOTION
- K950564 — RICH-MAR US-II ULTRASOUND
- K922839 — MID-CANADA MEDICAL
- K930186 — INTERTRON 6000/6100
- K930307 — INTELECT 222 P
- K920983 — SONOPULS 590
- K923076 — ULTRA SX
- K915557 — RICH-MAR MODEL 510 ULTRASOUND
- K913981 — RICH-MAR MODEL II ULTRASOUND
- K912202 — RICH-MAR MODEL 25 ULTRASOUND
- K910708 — RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
- K904051 — RICH-MAR MODEL V ULTRASOUND
- K901950 — DITER ULTRASONIC S 3000
- K894152 — MEDITHERM
- K883228 — SONICATOR 720 (MODEL ME720)
- K881211 — TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
- K875381 — ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER
- K880901 — SONICATOR 710 (MODEL ME710)
- K880602 — MODIFIED SONICATOR 720, MODEL ME720
- K873812 — SONICATOR 720 (MODEL ME720)
- K872393 — SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
- K860099 — MEDCO-SONIC NQ-2000
- K851937 — SONOMED 4
- K851397 — SONICATOR 705 MODEL ME 705
- K850640 — SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT
- K844386 — ESCOTEK-EST 301A ULTRA-SONIC UNIT
- K844036 — US 610
- K843372 — OMNISOUND THERAPY UNIT
- K843221 — MEGASON MODEL 150
- K841445 — INTELECT 205 PORTABLE ULTRASOUND UNIT
- K841446 — INTELECT 200 THERAPEUTIC ULTRASOUND
- K841447 — INTELECT 210 PORTABLE ULTRASOUND
- K813593 — INTELECT MODEL 200
- K812752 — MICRO MED INT'L MICRO SOUND US-100
- K811159 — DYNASOUND 801
- K800632 — MODEL 118 PULSE MEGASON
- K791976 — DYNASOUND 601
- K781317 — ULTRASONIC THERAPY APPARATUS, 407
Data sourced from openFDA. This site is unofficial and independent of the FDA.