Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

FDA product code IMJ · 42 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5290
Review panel: PM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-10-04 – 2026-06-12

IMJ 2026-06-12

BTL-899TT

Applicant BTL Industries, Inc.

K number K252963

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IMJ 2025-11-05

ViVY

Applicant Viatherm Therapeutics, LLC

K number K250376

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IMJ 2025-06-25

Curapuls 670

Applicant Enraf-Nonius, B.V.

K number K243112

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IMJ 2023-05-24

Reprieve by RegenesisTM

Applicant Regenesis Biomedical, Inc.

K number K223620

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IMJ 2019-01-24

BTL-703

Applicant BTL Industries, Inc.

K number K182363

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IMJ 2018-05-01

ViaTherm BOOST

Applicant Viatherm Therapeutics, LLC

K number K173300

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IMJ 2016-11-17

ProMedTek Model C1400 Shortwave Diathermy Device

Applicant Promedtek, Inc.

K number K162240

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IMJ 2016-11-14

ThermoPro

Applicant Zimmer Medizinsysteme GmbH

K number K161862

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IMJ 2016-06-14

Megapulse III Shortwave Diathermy

Applicant Accelerated Care Plus

K number K153456

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IMJ 2012-10-05

BTL ELITE

Applicant BTL Industries, Inc.

K number K120093

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IMJ 2009-03-18

INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601

Applicant Chattanooga Group

K number K083433

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IMJ 2004-10-08

AUTO THERM 390, MODEL ME 390

Applicant Mettler Electronics Corp.

K number K042554

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IMJ 2003-04-01

SELITHERM, MODEL C100

Applicant Selicor, Inc.

K number K030382

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IMJ 2003-01-28

SW-180 SHORTWAVE THERAPY UNIT

Applicant Ito Co., Ltd.

K number K022846

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IMJ 2002-09-26

AUTO*THERM 395, MODEL ME 395

Applicant Mettler Electronics Corp.

K number K022458

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IMJ 2002-07-30

SELICOR, MODELS A100 & D100

Applicant Selicor, Inc.

K number K020227

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IMJ 1998-01-23

MEGAPULSE II

Applicant Pti

K number K973732

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IMJ 1997-04-03

ULTRATHERM (908)

Applicant Sie-Med, Inc.

K number K964083

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IMJ 1997-02-21

THEE THERMASTIM

Applicant Ehti Medical Corp.

K number K962703

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IMJ 1997-02-21

VASOTHERM

Applicant Ehti Medical Corp.

K number K962243

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IMJ 1995-02-17

MAGNATHERM MODEL 1000 SS

Applicant Intl. Medical Electronics , Ltd.

K number K934151

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IMJ 1987-05-28

TRU-SOUND ULTRASOUND THERAPY UNIT

Applicant Tru-Trac Therapy Products, Inc.

K number K871633

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IMJ 1987-03-12

SOUNDTEK MODEL UT-4700

Applicant Soundtek, Inc.

K number K864766

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IMJ 1986-12-29

MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS

Applicant Rich-Mar Corp.

K number K864653

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IMJ 1986-09-25

THE BIO-TEK UW-II

Applicant Bio-Tek Instruments, Inc.

K number K862932

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IMJ 1986-08-01

ULTRATHERM 808 I

Applicant Elmed, Inc.

K number K862589

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IMJ 1986-07-23

NEMECTROSON MODEL 2

Applicant Nemectron Medical, Inc.

K number K862376

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IMJ 1986-07-14

MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT

Applicant I-Rep, Inc.

K number K861864

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IMJ 1986-07-10

RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC

Applicant Rich-Mar Corp.

K number K862469

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IMJ 1986-07-10

RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC

Applicant Rich-Mar Corp.

K number K862468

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IMJ 1986-05-30

CURAPULS 419 DIATHERMY UNIT

Applicant Henley Intl.

K number K861248

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IMJ 1986-05-30

CURAMED 402 DIATHERMY UNIT

Applicant Henley Intl.

K number K861247

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IMJ 1985-09-30

THERMO SHORTWAVE DIATHERMY

Applicant Zimmer Elektromedizin GmbH

K number K852166

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IMJ 1985-05-17

CURAMED 402

Applicant Fluidotherapy Corp.

K number K850573

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IMJ 1985-03-12

THERMOPULS E

Applicant Nemectron Medical, Inc.

K number K844416

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IMJ 1984-08-01

ULTRAMED 11S601

Applicant Robert Bosch Corp.

K number K842801

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IMJ 1984-05-31

MEGA PULSE THERAPY UNIT

Applicant Physio Technology, Inc.

K number K841874

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IMJ 1978-12-07

SIEMENS ULTRATHERM 708

Applicant Elmed, Inc.

K number K781455

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IMJ 1978-09-27

SHORTWAVE THERAPY APPAR. CURAMED 401

Applicant General Theraphysical, Inc.

K number K781320

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IMJ 1978-09-27

PULSED AND CONTINUOUS SHORTWAVE APPAR.

Applicant General Theraphysical, Inc.

K number K781316

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IMJ 1978-05-12

SHORTWAVE DIATHERMY MODEL 802

Applicant Birtcher Corp.

K number K780755

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IMJ 1977-10-04

MAGNATHERM 2000

Applicant Intl. Medical Electronics , Ltd.

K number K771540

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