Product Code: IMJ
FDA class 2
21 CFR 890.5290
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Physical Medicine
Shortwave Diathermy for Applying Therapeutic Deep Heat is a Physical Medicine device that uses high-frequency electromagnetic energy in the shortwave radiofrequency range to generate deep tissue heating within muscles and joints, used to reduce pain, relieve muscle spasm, and increase local circulation. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IMJ, regulated under 21 CFR 890.5290, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.
510(k)s
43
FEI Numbers
14
Registration Numbers
14
Unique Applicants
33
Years Active
48
Basic Information
- Product Code
- IMJ
- Device Class
- FDA class 2
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 43 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243112 | Curapuls 670 | Jun 25, 2025 | Substantially Equivalent | Enraf-Nonius, B.V. |
| K223620 | Reprieve by RegenesisTM | May 24, 2023 | Substantially Equivalent | Regenesis Biomedical Inc. |
| K182363 | BTL-703 | Jan 24, 2019 | Substantially Equivalent | BTL Industries, Inc. |
| K173300 | ViaTherm BOOST | May 01, 2018 | Substantially Equivalent | ViaTherm Therapeutics, Llc. |
| K162240 | ProMedTek Model C1400 Shortwave Diathermy Device | Nov 17, 2016 | Substantially Equivalent | PROMEDTEK INC. |
| K161862 | ThermoPro | Nov 14, 2016 | Substantially Equivalent | Zimmer MedizinSysteme GmbH |
| K153456 | Megapulse III Shortwave Diathermy | Jun 14, 2016 | Substantially Equivalent | Accelerated Care Plus |
| K131926 | THERMOPULSE | Jul 24, 2014 | Substantially Equivalent | IBRAMED EQUIPAMENTOS MEDICOS |
| K131899 | SW-THERM | Mar 14, 2014 | Substantially Equivalent | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
| K121123 | BIOFUSIONARY BEBE | Mar 10, 2014 | Substantially Equivalent | ROCKY MOUNTAIN BIOSYSTEMS, INC. |
| K120093 | BTL ELITE | Oct 05, 2012 | Substantially Equivalent | BTL INDUSTRIES, INC |
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | Mar 18, 2009 | Substantially Equivalent | CHATTANOOGA GROUP |
| K042554 | AUTO THERM 390, MODEL ME 390 | Oct 08, 2004 | Substantially Equivalent | METTLER ELECTRONICS CORP. |
| K030382 | SELITHERM, MODEL C100 | Apr 01, 2003 | Substantially Equivalent | SELICOR, INC. |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Jan 28, 2003 | Substantially Equivalent | ITO CO., LTD. |
| K022458 | AUTO*THERM 395, MODEL ME 395 | Sep 26, 2002 | Substantially Equivalent | METTLER ELECTRONICS CORP. |
| K020227 | SELICOR, MODELS A100 & D100 | Jul 30, 2002 | Substantially Equivalent | SELICOR, INC. |
| K973732 | MEGAPULSE II | Jan 23, 1998 | Substantially Equivalent | PTI |
| K964083 | ULTRATHERM (908) | Apr 03, 1997 | Substantially Equivalent | SIE-MED, INC. |
| K962703 | THEE THERMASTIM | Feb 21, 1997 | Substantially Equivalent | EHTI MEDICAL CORP. |
| K962243 | VASOTHERM | Feb 21, 1997 | Substantially Equivalent | EHTI MEDICAL CORP. |
| K934151 | MAGNATHERM MODEL 1000 SS | Feb 17, 1995 | Substantially Equivalent | INTL. MEDICAL ELECTRONICS LTD. |
| K871633 | TRU-SOUND ULTRASOUND THERAPY UNIT | May 28, 1987 | Substantially Equivalent | TRU-TRAC THERAPY PRODUCTS, INC. |
| K864766 | SOUNDTEK MODEL UT-4700 | Mar 12, 1987 | Substantially Equivalent | SOUNDTEK, INC. |
| K864653 | MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS | Dec 29, 1986 | Substantially Equivalent | RICH-MAR CORP. |
| K862932 | THE BIO-TEK UW-II | Sep 25, 1986 | Substantially Equivalent | BIO-TEK INSTRUMENTS, INC. |
| K862589 | ULTRATHERM 808 I | Aug 01, 1986 | Substantially Equivalent | ELMED, INC. |
| K862376 | NEMECTROSON MODEL 2 | Jul 23, 1986 | Substantially Equivalent | NEMECTRON MEDICAL, INC. |
| K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT | Jul 14, 1986 | Substantially Equivalent | I-REP, INC. |
| K862469 | RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC | Jul 10, 1986 | Substantially Equivalent | RICH-MAR CORP. |
| K862468 | RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC | Jul 10, 1986 | Substantially Equivalent | RICH-MAR CORP. |
| K861248 | CURAPULS 419 DIATHERMY UNIT | May 30, 1986 | Substantially Equivalent | HENLEY INTL. |
| K861247 | CURAMED 402 DIATHERMY UNIT | May 30, 1986 | Substantially Equivalent | HENLEY INTL. |
| K852166 | THERMO SHORTWAVE DIATHERMY | Sep 30, 1985 | Substantially Equivalent for Some Indications | ZIMMER ELEKTROMEDIZIN GMBH |
| K850573 | CURAMED 402 | May 17, 1985 | Substantially Equivalent | FLUIDOTHERAPY CORP. |
| K844416 | THERMOPULS E | Mar 12, 1985 | Substantially Equivalent | NEMECTRON MEDICAL, INC. |
| K842801 | ULTRAMED 11S601 | Aug 01, 1984 | Substantially Equivalent | ROBERT BOSCH CORP. |
| K841874 | MEGA PULSE THERAPY UNIT | May 31, 1984 | Substantially Equivalent | PHYSIO TECHNOLOGY, INC. |
| K781455 | SIEMENS ULTRATHERM 708 | Dec 07, 1978 | Substantially Equivalent | ELMED, INC. |
| K781320 | SHORTWAVE THERAPY APPAR. CURAMED 401 | Sep 27, 1978 | Substantially Equivalent | GENERAL THERAPHYSICAL, INC. |
| K781316 | PULSED AND CONTINUOUS SHORTWAVE APPAR. | Sep 27, 1978 | Substantially Equivalent | GENERAL THERAPHYSICAL, INC. |
| K780755 | SHORTWAVE DIATHERMY MODEL 802 | May 12, 1978 | Substantially Equivalent | BIRTCHER CORP. |
| K771540 | MAGNATHERM 2000 | Oct 04, 1977 | Substantially Equivalent | INTL. MEDICAL ELECTRONICS LTD. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.