Product code IMJ— Physical Medicine
AUTO THERM 390, MODEL ME 390
- Classification name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device class
- Class 2
- Regulation
- 21 CFR 890.5290
- Advisory panel
- Physical Medicine
- Total cleared
- 45
- First cleared
- Most recent
Market context for product code IMJ
FDA has cleared devices under product code IMJ between 1977 and 2026, filed by 32 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2023
- 2019
- 2018
- 2016
- 2014
- 2012
- 2009
- 2004
- 2003
- 2002
- 1998
- 1997
- 1995
Top applicants under product code IMJ
Recent clearances under product code IMJ
- K252963 — BTL-899TT
- K250376 — ViVY
- K243112 — Curapuls 670
- K223620 — Reprieve by RegenesisTM
- K182363 — BTL-703
- K173300 — ViaTherm BOOST
- K162240 — ProMedTek Model C1400 Shortwave Diathermy Device
- K161862 — ThermoPro
- K153456 — Megapulse III Shortwave Diathermy
- K131926 — THERMOPULSE
- K131899 — SW-THERM
- K121123 — BIOFUSIONARY BEBE
- K120093 — BTL ELITE
- K083433 — INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601
- K042554 — AUTO THERM 390, MODEL ME 390
- K030382 — SELITHERM, MODEL C100
- K022846 — SW-180 SHORTWAVE THERAPY UNIT
- K022458 — AUTO*THERM 395, MODEL ME 395
- K020227 — SELICOR, MODELS A100 & D100
- K973732 — MEGAPULSE II
- K964083 — ULTRATHERM (908)
- K962243 — VASOTHERM
- K962703 — THEE THERMASTIM
- K934151 — MAGNATHERM MODEL 1000 SS
- K871633 — TRU-SOUND ULTRASOUND THERAPY UNIT
- K864766 — SOUNDTEK MODEL UT-4700
- K864653 — MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
- K862932 — THE BIO-TEK UW-II
- K862589 — ULTRATHERM 808 I
- K862376 — NEMECTROSON MODEL 2
- K861864 — MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT
- K862468 — RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC
- K862469 — RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC
- K861247 — CURAMED 402 DIATHERMY UNIT
- K861248 — CURAPULS 419 DIATHERMY UNIT
- K852166 — THERMO SHORTWAVE DIATHERMY
- K850573 — CURAMED 402
- K844416 — THERMOPULS E
- K842801 — ULTRAMED 11S601
- K841874 — MEGA PULSE THERAPY UNIT
- K781455 — SIEMENS ULTRATHERM 708
- K781316 — PULSED AND CONTINUOUS SHORTWAVE APPAR.
- K781320 — SHORTWAVE THERAPY APPAR. CURAMED 401
- K780755 — SHORTWAVE DIATHERMY MODEL 802
- K771540 — MAGNATHERM 2000
Data sourced from openFDA. This site is unofficial and independent of the FDA.