IMFClass I
Unit, Chilling
Physical Medicine · 21 CFR 890.5940
MDR events9All time
Recalls1All time
Registered firms12Currently listed
510(k) clearances2All time
Recent MDR events
9 adverse event reports on file
- C-5 120VSep 23, 2008InjuryChattanooga Group1022819-2008-00257
- PACK COLD INSTANT MEDIUMNov 22, 2004InjuryCardinal Health1423507-2004-00122
- INSTANT COLD PACKJun 17, 2003MalfunctionCardinal Health1423507-2003-00081
- INSTANT COLD PACKNov 21, 2001MalfunctionAllegiance Healthcare Corporation1423507-2001-00277
- INSTANT COLD PACKJun 13, 2001InjuryAllegiance Healthcare Corp1423507-2001-00169
- T305 BIO-COOL ATC COLD THERAPY UNITApr 23, 2001OtherDeroyal Inc.1055236-2001-00001
- ST100 THERMAL THERAPY SYSTEMAug 29, 1996InjuryBurke Neutech40838
- TEMPTEK KNEE BLANKETMar 14, 1996InjuryTemptek, Inc.2242816-1996-00023
- THERAPEUTIC COOLING UNITSep 24, 1993InjuryTemptek, Inc.2244652-1993-00001
Event type breakdown
Injury6
Malfunction2
Other1
Recalls
1 recall events for this product code
Registered firms
12 firms currently registered for this product code
Weg Surgical Solutions
Greensboro, NC, US
Nadir & Co.
Sialkot Punjab, PK
Csafe Global
Dayton, OH, US
Novetec Group Ltd.
Kowloon, HK
Djo, Llc
Carlsbad, CA, US
Linjiang (holdings) Limited
Shangqiu Henan, CN
Dongguan Quanding Medical Supplies Co., Ltd
Dongguan Guangdong, CN
Kiyou Jochugiku
Kainan Wakayama, JP
Novex Innovations, Llc
Winston Salem, NC, US
Tryptech Services
Greensboro, NC, US
Shenzhen City U-lucky Sporting Goods Co., Ltd.
Shenzhen Guangdong, CN
Dj Orthopedics De Mexico, S.a. De C.v.
TIJUANA Baja California, MX
510(k) clearances
2 clearances for this product code