Atlas FDA

IMJ

45 FDA 510(k) clearances · Product code

106 daysmedian time to decision
268 days90th percentile
45clearances measured

FDA profile

Official device name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5290
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
1992: 1 · 2000: 1 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BTL-899TT (K252963)BTL Industries, Inc.2026-06-12
ViVY (K250376)Viatherm Therapeutics, LLC2025-11-05
Curapuls 670 (K243112)Enraf-Nonius, B.V.2025-06-25
Reprieve by RegenesisTM (K223620)Regenesis Biomedical, Inc.2023-05-24
BTL-703 (K182363)BTL Industries, Inc.2019-01-24
ViaTherm BOOST (K173300)Viatherm Therapeutics, LLC2018-05-01
ProMedTek Model C1400 Shortwave Diathermy Device (K162240)Promedtek, Inc.2016-11-17
ThermoPro (K161862)Zimmer Medizinsysteme GmbH2016-11-14
Megapulse III Shortwave Diathermy (K153456)Accelerated Care Plus2016-06-14
THERMOPULSE (K131926)Ibramed Equipamentos Medicos2014-07-24
SW-THERM (K131899)Shenzhen Dongdixin Technology Co., Ltd.2014-03-14
BIOFUSIONARY BEBE (K121123)Rocky Mountain Biosystems, Inc.2014-03-10
BTL ELITE (K120093)BTL Industries, Inc.2012-10-05
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 (K083433)Chattanooga Group2009-03-18
AUTO THERM 390, MODEL ME 390 (K042554)Mettler Electronics Corp.2004-10-08
SELITHERM, MODEL C100 (K030382)Selicor, Inc.2003-04-01
SW-180 SHORTWAVE THERAPY UNIT (K022846)Ito Co., Ltd.2003-01-28
AUTO*THERM 395, MODEL ME 395 (K022458)Mettler Electronics Corp.2002-09-26
SELICOR, MODELS A100 & D100 (K020227)Selicor, Inc.2002-07-30
MEGAPULSE II (K973732)Pti1998-01-23
ULTRATHERM (908) (K964083)Sie-Med, Inc.1997-04-03
VASOTHERM (K962243)Ehti Medical Corp.1997-02-21
THEE THERMASTIM (K962703)Ehti Medical Corp.1997-02-21
MAGNATHERM MODEL 1000 SS (K934151)Intl. Medical Electronics , Ltd.1995-02-17
TRU-SOUND ULTRASOUND THERAPY UNIT (K871633)Tru-Trac Therapy Products, Inc.1987-05-28
SOUNDTEK MODEL UT-4700 (K864766)Soundtek, Inc.1987-03-12
MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS (K864653)Rich-Mar Corp.1986-12-29
THE BIO-TEK UW-II (K862932)Bio-Tek Instruments, Inc.1986-09-25
ULTRATHERM 808 I (K862589)Elmed, Inc.1986-08-01
NEMECTROSON MODEL 2 (K862376)Nemectron Medical, Inc.1986-07-23
MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT (K861864)I-Rep, Inc.1986-07-14
RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC (K862469)Rich-Mar Corp.1986-07-10
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC (K862468)Rich-Mar Corp.1986-07-10
CURAPULS 419 DIATHERMY UNIT (K861248)Henley Intl.1986-05-30
CURAMED 402 DIATHERMY UNIT (K861247)Henley Intl.1986-05-30
THERMO SHORTWAVE DIATHERMY (K852166)Zimmer Elektromedizin GmbH1985-09-30
CURAMED 402 (K850573)Fluidotherapy Corp.1985-05-17
THERMOPULS E (K844416)Nemectron Medical, Inc.1985-03-12
ULTRAMED 11S601 (K842801)Robert Bosch Corp.1984-08-01
MEGA PULSE THERAPY UNIT (K841874)Physio Technology, Inc.1984-05-31
SIEMENS ULTRATHERM 708 (K781455)Elmed, Inc.1978-12-07
PULSED AND CONTINUOUS SHORTWAVE APPAR. (K781316)General Theraphysical, Inc.1978-09-27
SHORTWAVE THERAPY APPAR. CURAMED 401 (K781320)General Theraphysical, Inc.1978-09-27
SHORTWAVE DIATHERMY MODEL 802 (K780755)Birtcher Corp.1978-05-12
MAGNATHERM 2000 (K771540)Intl. Medical Electronics , Ltd.1977-10-04

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