LSBClass II
Unit, Fluidotherapy
Physical Medicine · 21 CFR 890.5100
MDR events13All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances4All time
Recent MDR events
13 adverse event reports on file
- CHATTANOOGASep 23, 2025MalfunctionDjo Llc9616086-2025-00059
- FLUIDOTHERAPYJan 31, 2025InjuryDj Orthopedics De Mexico, S.a. De C.v.MW5165598
- FLUIDOTHERAPY FT110 SINGLESep 27, 2021InjuryDjo Llc9616086-2021-00015
- CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITYOct 23, 2019MalfunctionDjo, Llc9616086-2019-00077
- CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITYJul 31, 2019MalfunctionDjo, Llc9616086-2019-00053
- WHITEHALL MANUFACTURINGJun 5, 2018MalfunctionWhitehall Manufacturing1000150265-2018-00001
- DONJOYJun 18, 2015InjuryDjo, Llc9616086-2015-00014
- CHATTANOOGAJun 4, 2015InjuryDjo, Llc9616086-2015-00013
- FLUIDOTHERAPYJan 23, 2015InjuryChattanooga Djo, LlcMW5040428
- FLUIDOTHERAPY FT110 SINGLEMay 24, 2011InjuryDj Orthopedics De Mexico9616086-2011-00066
Event type breakdown
Malfunction7
Injury6
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Thermo-Electric Co.Aug 3, 2001
K011768 · THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
- Chattanooga Group, Inc.Jul 6, 2001
K011243 · CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
- Henley Intl.Jan 18, 1991
K896817 · MODEL T11 FLUIDOTHERAPY UNIT
- Henley Intl.Sep 4, 1987
K871802 · MODEL K210 AND K211 FLUIDOTHERAPY UNITS