FDA Product Code
FDA Product Code IMI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5300
510(k) Clearances — 89 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025-06-04 | Traditional | PDF ↗ |
| K230472 | Sonopuls 190 | Enraf-Nonius, B.V. | 2023-10-24 | Traditional | PDF ↗ |
| K222098 | ManaSport+ | Manamed, Inc. | 2023-03-08 | Traditional | PDF ↗ |
| K210284 | ManaSport | Manamed, Inc. | 2022-04-26 | Traditional | PDF ↗ |
| K202788 | Sonomed IV, Sonomed V | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | 2021-12-23 | Traditional | PDF ↗ |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | Brh Medical , Ltd. | 2017-08-25 | Traditional | PDF ↗ |
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016-11-10 | Abbreviated | PDF ↗ |
| K160075 | Accent XL | Alma Lasers, Inc. | 2016-08-17 | Traditional | PDF ↗ |
| K161502 | MC1 Plus | General Project S.R.L. | 2016-08-16 | Special | PDF ↗ |
| K142976 | UltraTENS | Shenzhen Dongdixin Technology Co., Ltd. | 2015-08-26 | Traditional | PDF ↗ |
| K131309 | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ | Ibramed Equipamentos Medicos | 2014-01-27 | Traditional | PDF ↗ |
| K130888 | SONOPULSE/ SONOPULSE III | Ibramed- Industria Brazileria DE Equipamentos Medi | 2014-01-09 | Traditional | PDF ↗ |
| K124010 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2013-08-23 | Traditional | PDF ↗ |
| K120171 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2012-05-04 | Special | PDF ↗ |
| K112520 | US-101L, US-103S | Ito Co., Ltd. | 2011-10-26 | Traditional | PDF ↗ |
| K091615 | MED CONTOUR | General Project S.R.L. | 2010-05-06 | Traditional | PDF ↗ |
| K090542 | SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 | Sun-Rain System Corp. | 2009-10-23 | Traditional | PDF ↗ |
| K062256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM | Hill Laboratories Co. | 2007-02-26 | Traditional | PDF ↗ |
| K053041 | MED SCULPT | General Project S.R.L. | 2006-08-02 | Traditional | PDF ↗ |
| K052934 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | S.O.R. Internacional, S.A. | 2006-06-12 | Traditional | PDF ↗ |
| K053546 | SONICATOR 740, MODEL ME 740 | Mettler Electronics Corp. | 2006-05-04 | Abbreviated | PDF ↗ |
| K050410 | HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) | Hwang Sun Enterprise Co., Ltd. | 2005-07-14 | Traditional | PDF ↗ |
| K040798 | HES ULTRASONIC THERAPY APPLIANCE | Hwang Sun Enterprise Co., Ltd. | 2004-08-04 | Traditional | PDF ↗ |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | Chattanooga Group | 2003-12-03 | Traditional | PDF ↗ |
| K024013 | SUN-RAIN ULTRASONIC THERAPY, SU-100 | Sun-Rain System Corp. | 2003-10-31 | Traditional | PDF ↗ |
| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | Dynatronics Corp. | 2003-10-22 | Traditional | PDF ↗ |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | Ito Co., Ltd. | 2003-10-09 | Traditional | PDF ↗ |
| K024307 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Sybaritic, Inc. | 2003-07-02 | Traditional | PDF ↗ |
| K030878 | ACCOUSONIC, MODEL AS-270 | Metron Medical Australia, Pty, Ltd. | 2003-03-28 | Special | PDF ↗ |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | Metron Medical Australia, Pty, Ltd. | 2003-02-20 | Special | PDF ↗ |
| K021483 | RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND | Rich-Mar Corp. | 2002-09-13 | Traditional | PDF ↗ |
| K013192 | SONICATOR PLUS 930, MODEL ME 930 | Mettler Electronics Corp. | 2001-10-17 | Abbreviated | PDF ↗ |
| K010702 | XUB EXTERNAL ULTRASOUND | Kmi Kolster Methods, Inc. | 2001-08-09 | Traditional | PDF ↗ |
| K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | 2001-07-16 | Special | PDF ↗ |
| K010609 | ACCUSONIC, MODEL AS-260 | Metron Medical Australia, Pty, Ltd. | 2001-03-16 | Special | PDF ↗ |
| K010102 | SONIC MODEL SO-300 | Metron Medical Australia, Pty, Ltd. | 2001-02-09 | Special | PDF ↗ |
| K991613 | SW ULTRASOUND, MODELS 331, 311, 333 | Starbene | 2000-12-08 | Traditional | PDF ↗ |
| K000084 | ENRAF-NONIUS SONOPULS 190 SYSTEM | Henley Healthcare, Inc. | 2000-08-04 | Traditional | PDF ↗ |
| K000593 | SONIC, MODEL SO-100 | Metron Medical Australia, Pty, Ltd. | 2000-08-04 | Traditional | PDF ↗ |
| K001370 | ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | 2000-07-17 | Traditional | PDF ↗ |
| K000604 | NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT | Naturopathic Laboratories International, Inc. | 2000-05-23 | Traditional | PDF ↗ |
| K984199 | EXONIX | Fibra Sonics, Inc. | 1999-02-17 | Traditional | PDF ↗ |
| K981449 | SD-956 ULTRASOUND THERAPY | Skylark Device Co., Ltd. | 1998-12-11 | Traditional | PDF ↗ |
| K982544 | RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES | Rich-Mar Corp. | 1998-11-19 | Traditional | PDF ↗ |
| K982829 | FORTE, MODEL CPS ULTRASOUND | Chattanooga Group, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K973024 | INTELECT LEGEND ULTRASOUND | Chattanooga Group, Inc. | 1997-11-10 | Traditional | PDF ↗ |
| K970131 | ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE | C.L. Mcintosh & Assoc., Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K961250 | DYNATRON 125 ULTRASOUND | Dynatronics Corp. | 1996-08-26 | Traditional | PDF ↗ |
| K960802 | CUSHMAN MANUFACTURING, INC. ULTRA 6.0. | Cushman Mfg., Inc. | 1996-06-18 | Traditional | PDF ↗ |
| K954136 | MATRIX MICROSON 410 | Matrix Biokinetics, Inc. | 1996-04-01 | Traditional | PDF ↗ |
| K952536 | SONO 5 | Zimmer Elektromedizin GmbH | 1996-03-05 | Traditional | PDF ↗ |
| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | Chester Labs, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K950564 | RICH-MAR US-II ULTRASOUND | Rich-Mar Corp. | 1995-05-15 | Traditional | PDF ↗ |
| K930186 | INTERTRON 6000/6100 | Williams Healthcare Systems, LLC | 1993-07-02 | Traditional | PDF ↗ |
| K930307 | INTELECT 222 P | Chattanooga Group, Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K922839 | MID-CANADA MEDICAL | Mid-Canada Medical | 1993-07-02 | Traditional | PDF ↗ |
| K923076 | ULTRA SX | Excel Tech. , Ltd. | 1993-03-09 | Traditional | PDF ↗ |
| K920983 | SONOPULS 590 | Henley Intl. | 1993-03-09 | Traditional | PDF ↗ |
| K915557 | RICH-MAR MODEL 510 ULTRASOUND | Rich-Mar Corp. | 1992-03-10 | Traditional | PDF ↗ |
| K913981 | RICH-MAR MODEL II ULTRASOUND | Rich-Mar Corp. | 1991-11-13 | Traditional | PDF ↗ |
| K912202 | RICH-MAR MODEL 25 ULTRASOUND | Rich-Mar Corp. | 1991-09-17 | Traditional | PDF ↗ |
| K910708 | RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE | Rich-Mar Corp. | 1991-05-21 | Traditional | PDF ↗ |
| K904051 | RICH-MAR MODEL V ULTRASOUND | Rich-Mar Corp. | 1991-01-14 | Traditional | PDF ↗ |
| K901950 | DITER ULTRASONIC S 3000 | Diter Elektroniikka OY | 1990-07-27 | Traditional | PDF ↗ |
| K894152 | MEDITHERM | Medical Equipment Designs, Inc. | 1990-06-11 | Traditional | PDF ↗ |
| K883228 | SONICATOR 720 (MODEL ME720) | Mettler Electronics Corp. | 1988-08-18 | Traditional | PDF ↗ |
| K881211 | TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 | Tru-Trac Therapy Products, Inc. | 1988-05-11 | Traditional | PDF ↗ |
| K875381 | ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER | Ford Laboratories, Inc. | 1988-05-03 | Traditional | PDF ↗ |
| K880901 | SONICATOR 710 (MODEL ME710) | Mettler Electronics Corp. | 1988-03-17 | Traditional | PDF ↗ |
| K880602 | MODIFIED SONICATOR 720, MODEL ME720 | Mettler Electronics Corp. | 1988-02-25 | Traditional | PDF ↗ |
| K873812 | SONICATOR 720 (MODEL ME720) | Mettler Electronics Corp. | 1987-12-10 | Traditional | PDF ↗ |
| K872393 | SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT | Henley Intl. | 1987-07-23 | Traditional | PDF ↗ |
| K860099 | MEDCO-SONIC NQ-2000 | Medco Products, Co., Inc. | 1986-04-09 | Traditional | PDF ↗ |
| K851937 | SONOMED 4 | Robert Bosch Corp. | 1985-07-17 | Traditional | PDF ↗ |
| K851397 | SONICATOR 705 MODEL ME 705 | Mettler Electronics Corp. | 1985-07-02 | Traditional | PDF ↗ |
| K850640 | SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT | Fluidotherapy Corp. | 1985-05-14 | Traditional | PDF ↗ |
| K844386 | ESCOTEK-EST 301A ULTRA-SONIC UNIT | Nor-Am Patient Care Products, Inc. | 1985-05-01 | Traditional | PDF ↗ |
| K844036 | US 610 | Rich-Mar Corp. | 1984-11-27 | Traditional | PDF ↗ |
| K843372 | OMNISOUND THERAPY UNIT | Physio Technology, Inc. | 1984-09-18 | Traditional | PDF ↗ |
| K843221 | MEGASON MODEL 150 | Birtcher Corp. | 1984-08-24 | Traditional | PDF ↗ |
| K841447 | INTELECT 210 PORTABLE ULTRASOUND | Chattanooga Group, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K841445 | INTELECT 205 PORTABLE ULTRASOUND UNIT | Chattanooga Group, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K841446 | INTELECT 200 THERAPEUTIC ULTRASOUND | Chattanooga Group, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K813593 | INTELECT MODEL 200 | Chattanooga Group, Inc. | 1982-02-22 | Traditional | PDF ↗ |
| K812752 | MICRO MED INT'L MICRO SOUND US-100 | N-Tron Electronics | 1982-01-19 | Traditional | PDF ↗ |
| K811159 | DYNASOUND 801 | Dynawave, Corp. | 1981-05-27 | Traditional | PDF ↗ |
| K800632 | MODEL 118 PULSE MEGASON | Birtcher Corp. | 1980-05-02 | Traditional | PDF ↗ |
| K791976 | DYNASOUND 601 | Dynawave, Corp. | 1980-01-09 | Traditional | PDF ↗ |
| K781317 | ULTRASONIC THERAPY APPARATUS, 407 | General Theraphysical, Inc. | 1978-10-03 | Traditional | PDF ↗ |
Product code IMI · Class II · Physical Medicine. Data: openFDA.