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IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Class II

FDA Device Classification

FDA product code IMJ covers "Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat", a Class II medical device regulated under 21 CFR 890.5290. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IMJ
Device Class
Class II
Regulation Number
890.5290
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252963Btl IndustriesBTL-899TTJun 12, 2026
K250376Viatherm TherapeuticsViVYNov 5, 2025
K243112Enraf-NoniusCurapuls 670Jun 25, 2025
K223620Regenesis BiomedicalReprieve by RegenesisTMMay 24, 2023
K182363Btl IndustriesBTL-703Jan 24, 2019
K173300Viatherm TherapeuticsViaTherm BOOSTMay 1, 2018
K162240PromedtekProMedTek Model C1400 Shortwave Diathermy DeviceNov 17, 2016
K161862Zimmer MedizinsystemeThermoProNov 14, 2016
K153456Accelerated Care PlusMegapulse III Shortwave DiathermyJun 14, 2016
K131926Ibramed Equipamentos MedicosTHERMOPULSEJul 24, 2014
K131899Shenzhen Dongdixin Technology CoSW-THERMMar 14, 2014
K121123Rocky Mountain BiosystemsBIOFUSIONARY BEBEMar 10, 2014
K120093Btl IndustriesBTL ELITEOct 5, 2012
K083433Chattanooga GroupINTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601Mar 18, 2009
K042554Mettler ElectronicsAUTO THERM 390, MODEL ME 390Oct 8, 2004
K030382SelicorSELITHERM, MODEL C100Apr 1, 2003
K022846Ito CoSW-180 SHORTWAVE THERAPY UNITJan 28, 2003
K022458Mettler ElectronicsAUTO*THERM 395, MODEL ME 395Sep 26, 2002
K020227SelicorSELICOR, MODELS A100 & D100Jul 30, 2002
K973732PtiMEGAPULSE IIJan 23, 1998

FDA data resources