Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Physical Medicine · 21 CFR 890.5300
Recent MDR events
60 adverse event reports on file
- SOLARIS 709 PLUSAug 5, 2025MalfunctionDynatronics CorpMW5174064
- CHATTANOOGAMay 23, 2025InjuryDjo Llc9616086-2025-00052
- CHATTANOOGAJul 13, 2024InjuryDjo Llc9616086-2024-00053
- HILL LABORATORIES HF54Feb 9, 2022InjuryHill LaboratoriesMW5107350
- DYNATRONICS CORP ULTRASOUND STIMULATION UNITNov 2, 2021InjuryMW5105094
- RICHMARJul 19, 2021MalfunctionCompass Health Brands3012316249-2021-00024
- RICHMARFeb 8, 2021MalfunctionCompass Health Brands3012316249-2021-00005
- RICHMARJan 27, 2021MalfunctionCompass Health Brands3012316249-2021-00004
- RICHMAROct 14, 2020MalfunctionCompass Health Brands3012316249-2020-00031
- RICHMARAug 25, 2020MalfunctionCompass Health Brands3012316249-2020-00026
Event type breakdown
Recalls
3 recall events for this product code
- Chattanooga Corp IncTerminatedAug 6, 2008
VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.
Device may fail to administer therapy during use.
Z-1636-2008 · View FDA record ↗ - Chattanooga Corp IncTerminatedAug 6, 2008
INTELECT TRANSPORT ULTRASOUND, electromechanical therapeutic ultrasound device, Model No. 2782, Chattanooga Group.
Device may fail to administer therapy during use.
Z-1639-2008 · View FDA record ↗ - Sybaritic, IncTerminatedMar 9, 2005
Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
Device is performing functions that are not cleared in the 510(k).
Z-0578-05 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Enraf-nonius B.v.
ROTTERDAM Zuid-Holland, NL
Zimmer Medizinsysteme Gmbh
NEU-ULM Bavaria, DE
Bausch & Lomb Incorporated
Rochester, NY, US
Mettler Electronics Corp.
ANAHEIM, CA, US
Djo, Llc
Carlsbad, CA, US
Preferred Depot
Irvine, CA, US
Grandway Technology (shenzhen) Limited
Shenzhen Guangdong, CN
Compass Health Brands (corporate Office)
Middleburg Heights, OH, US
Alma Lasers Ltd.
CAESAREA Northern, IL
Hironic Co., Ltd.
Yongin-Si Gyeonggi, KR
Ascentron, Inc.
White City, OR, US
Ibramed Industria Brasileira De Equipamentos Medicos Ltda
Amparo Sao Paulo, BR
Dj Orthopedics De Mexico, S.a. De C.v.
TIJUANA Baja California, MX
Jkh Health Co., Ltd.
Dongguan Guangdong, CN
Brh Medical Ltd
Jerusalem, IL
Harmony Health Tech Inc
Brooklyn, NY, US
Just Keep Healthy Co., Ltd.
Samkkei Munichay District Kampong Speu, KH
Imex, Llc
Fulton, MD, US
Manamed Llc
Denton, TX, US
510(k) clearances
89 clearances for this product code
- Jkh Health Co., Ltd.Jun 4, 2025
K240788 · Ultrasound Stimulator
- Enraf-Nonius, B.V.Oct 24, 2023
K230472 · Sonopuls 190
- Manamed, Inc.Mar 8, 2023
K222098 · ManaSport+
- Manamed, Inc.Apr 26, 2022
K210284 · ManaSport
- Carci Industria E Comercio DE Aparelhos Cirurgicos E OrtoDec 23, 2021
K202788 · Sonomed IV, Sonomed V
- Brh Medical , Ltd.Aug 25, 2017
K160378 · BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
- Bonutti Research, Inc.Nov 10, 2016
K161628 · JAS Pulse(TM) Ultrasonic Therapy
- Alma Lasers, Inc.Aug 17, 2016
K160075 · Accent XL