Atlas FDA

IMG

55 FDA 510(k) clearances · Product code

105 daysmedian time to decision
302 days90th percentile
55clearances measured

FDA profile

Official device name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5860
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 6 · 2011: 21 · 2012: 6 · 2019: 14 · 2021: 13 · 2022: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ultrasound Therapy Workstation (XMS-UET2) (K244041)Xemis Medical Technology (Shenzhen) Co., Ltd.2025-10-07
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System (K153559)Accelerated Care Plus (Acp)2016-08-26
ComboRehab (K150436)Shenzhen Dongdixin Technology Co., Ltd.2015-11-13
BTL-4000 (K150353)BTL Industries, Inc.2015-11-13
SONICSTIMU COMBO THERAPEUTIC DEVICE (K120217)Shenzhen Dongdixin Technology Co., Ltd.2012-11-21
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (K121059)Zimmer Medizinsystems GmbH2012-08-07
FUTURA (K102524)Dr. Oliver Wenker, M.D., M.B.A.2011-11-03
SONICATOR PLUS 920 (K111482)Mettler Electronics Corp.2011-08-25
WINSTIM (K102190)Johari Digital Healthcare , Ltd.2011-03-17
CT2011 SONICSTIMU PAIN RELIEF DEVICE (K092627)Shenzhen Dongdixin Technology Co., Ltd.2010-01-14
SONICATOR PLUS 940, MODEL ME940 (K071137)Mettler Electronics Corp.2007-08-01
TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K063728)Alfa Tech Medical Systems, Ltd.2007-04-04
SONIC-STIM (K063135)Naimco, Inc.2007-02-05
DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM (K052340)Alfa Tech Medical Systems, Ltd.2005-12-09
VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER (K040285)Chattanooga Group2004-04-12
DERMAWAVE 5000 COMBI MAX SYSTEM (K040121)Dermawave, LLC2004-03-17
VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (K031077)Chattanooga Group2003-12-11
VECTORSONIC, MODEL VU-270 (K030880)Metron Medical Australia, Pty, Ltd.2003-04-18
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI (K023050)Reliant Technologies, Inc.2003-02-14
VECTORSONIC, MODEL VU-200 (K020119)Metron Medical Australia, Pty, Ltd.2002-07-22
ULTRA V THERAPEUTIC ULTRASOUND (K001166)Excel Tech. , Ltd.2000-07-07
VECTRA COMBO (K982317)Chattanooga Group, Inc.1999-02-01
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO (K982830)Chattanooga Group, Inc.1998-11-06
FORTE (K953614)Chattanooga Group, Inc.1995-10-27
FORTE CB (K951746)Chattanooga Group, Inc.1995-06-21
SONICATOR 730 (K943469)Mettler Electronics Corp.1994-08-29
FORTE US (K941561)Chattanooga Group, Inc.1994-06-20
DYNATRON 150 (K935728)Dynatronics Corp.1994-04-26
FORTE US (K940180)Chattanooga Group, Inc.1994-04-15
DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR (K934287)Dynawave, Corp.1994-04-04
SONICATOR 716 (K934846)Mettler Electronics Corp.1994-03-23
THERAPEUTIC ULTRASOUND AND STIMULATOR (K935271)Chattanooga Group, Inc.1994-02-02
SONICATOR 715 (K934845)Mettler Electronics Corp.1994-01-21
DYNATRON 800 (K932937)Dynatronics Corp.1993-10-08
SONOPULS 591 (K922036)Henley Intl.1993-06-29
SONICATOR PLUS (K921436)Mettler Electronics Corp.1993-04-27
ULTRA III (K921952)Excel Tech. , Ltd.1993-03-09
DYNATRON 300 ULRASOUND (K920939)Dynatronics Laser Corp.1993-03-04
MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED (K923797)Rich-Mar Corp.1992-11-06
INTELECT, MODEL 245 (K911733)Chattanooga Group, Inc.1991-12-17
INTELECT 750 MP (K902875)Chattanooga Group, Inc.1990-09-27
INTELECT 170 (K902860)Chattanooga Group, Inc.1990-09-27
CURAPULS 403 DIATHERMY UNIT (K900189)Henley Intl.1990-09-18
ULTRA (THERAPEUTIC ULTRASOUND DEVICE) (K895690)Excel Tech. , Ltd.1990-02-20
OMNISOUND(TM) 3000 (K883893)Physio Technology, Inc.1988-11-01
SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION (K872909)Elmed, Inc.1988-01-13
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT (K872394)Henley Intl.1987-09-03
STIMULATOR, ULTRASOUND AND MUSCLE (K871647)Amy West1987-06-29
FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND (K861837)Fischer Industries, Inc.1986-08-07
RICH-MAR DELTA 330 HV (K844217)Rich-Mar Corp.1984-11-27
OMNISTIM II COMBIN. THERAPY SYS (K843351)Physio Technology, Inc.1984-09-18
INTELECT MODEL 700 (K813594)Chattanooga Group, Inc.1982-02-22
RICH-MAR HV II SELECT-A-PULSE (K810526)Rich-Mar Corp.1981-04-03
MUSCLE STIMULATOR (K772287)Rich-Mar Corp.1978-01-13
RM VI-HV (K771157)Rich-Mar Corp.1977-07-21

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Every clearance here is in the API, with alerts when new ones post.