Unit, Heating, Powered
Physical Medicine · 21 CFR 890.5950
Recent MDR events
38 adverse event reports on file
- CHATTANOOGADec 2, 2025MalfunctionDjo Llc9616086-2025-00071
- HYDROCOLLATOR HOTPAC PADSep 24, 2024MalfunctionDjo, Llc.MW5160029
- HYDRATHERMSep 7, 2022MalfunctionCompass Richmar, Llc15370589
- THERMALATORDec 9, 2021MalfunctionFabricacion Y Manufacturas De Mexico S.a.de C.v.1000150265-2021-00004
- RICHMARNov 11, 2021InjuryCompass Health Brands3012316249-2021-00032
- RICHMARJul 16, 2021MalfunctionCompass Health Brands3012316249-2021-00023
- RICHMARJun 18, 2021MalfunctionCompass Health Brands3012316249-2021-00020
- HYDRATHERM HEATER - STANDARD, TRADITIONAL RACK SYSTEM, 12X HYDRAHEAT PACKSMar 26, 2021MalfunctionCompass Richmar, Llc11574342
- RICHMARAug 21, 2020MalfunctionCompass Health Brands3012316249-2020-00025
- RICHMARFeb 26, 2020MalfunctionCompass Health Brands3012316249-2020-00011
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
48 firms currently registered for this product code
Djo, Llc
Carlsbad, CA, US
Gome Optical Lens Company Limited
Yonkers, NY, US
Shenzhen Shengbanghua Technology Development Co., Ltd.
Shenzhen Guangdong, CN
Tianjin Zhengtian Medical Instrument Co., Ltd.
Tianjin, CN
Novetec Group Ltd.
Kowloon, HK
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Jiangsu Moen Industrial Co.,ltd
Suqian Jiangsu, CN
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Zhongshan Bisen Plastic Electronic Products Co.,ltd
Zhongshan Guangdong, CN
Guangzhou Four E's Scientific Co., Ltd.
GUANGZHOU Guangdong, CN
Karis Co., Ltd.
Gimpo-si Gyeonggi, KR
Vadi Medical Technology Co., Ltd.
Taoyuan City, TW
Core Products International Inc
Chetek, WI, US
Oman Medical Beauty Manufacture Limited
Hong Kong, HK
Health Body World Supply, Inc. Dba The Wabbo Company
Lake Elsinore, CA, US
Hanil Medical Co., Ltd.
Gwangju-si, KR
Onlycare Inc
Denver, CO, US
Ibramed Industria Brasileira De Equipamentos Medicos Ltda
Amparo Sao Paulo, BR
Dongguan Quanding Medical Supplies Co., Ltd
Dongguan Guangdong, CN
Tutamen De Mexico, Llc
Tijuana Baja California, MX
Dj Orthopedics De Mexico, S.a. De C.v.
TIJUANA Baja California, MX
Grahope New Materials Technologies Inc.
Shenzhen Guangdong, CN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Marturion Electronics Ltd
Lisburn Northern Ireland, GB
Inion Oy
TAMPERE Pirkanmaa, FI
510(k) clearances
7 clearances for this product code
- Marda Medical, Inc.Sep 14, 2005
K050524 · EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
- Whitehall/Div Columbus Mckennon Corp.Mar 24, 1995
K950350 · THEMALATOR. MODELS T-4-S, T-8-S, ETC.
- FernoApr 14, 1993
K924023 · FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
- Fred Sammons, Inc.May 6, 1988
K880644 · ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
- Tri W-G, Inc.May 2, 1986
K861340 · R1750 AND R1424 POWERED HEATING UNITS
- Thermowave Medical Device Corp.Dec 9, 1983
K832177 · PULSAIR MODEL SP-1
- Tru-Eze Mfg. Co., Inc.Jul 28, 1980
K801625 · THERMOLATOR HEATING UNIT