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JFA — Exerciser, Finger, Powered Class I

FDA Device Classification

Classification Details

Product Code
JFA
Device Class
Class I
Regulation Number
890.5410
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K945803burke neutechTHERMAFLEX, MODEL SD 55 C.P.M.H.May 11, 1995
K931016jace systemsJACE MODEL H440 HAND CPM DEVICEJune 22, 1994
K933418bardon entHAND THERAPY ASSOSTApril 28, 1994
K921351jace systemsJACE MODEL PM-410 HAND CPM DEVICEMay 4, 1992
K900794toronto medicalMOBILIMB H3 HAND CPM UNITMarch 2, 1990
K900581buckman coDANNIFLEX CPM 880(TM)February 20, 1990
K880686toronto medicalTORONTO/MOBILIMB HAND C.P.M.February 26, 1988
K880336toronto medicalMOBILIMB HAND C.P.M. UNITFebruary 16, 1988
K860714buckman coACE AIM - CPM HAND UNITMarch 27, 1986
K844033danninger medical technologyMOBILIMB HAND UNITNovember 27, 1984
K830974sutter biomedicalSUTTER CPM 5000April 12, 1983
K790527maddakBURNETT-KETCHUM DYNAMIC HAND EXERCISERMarch 22, 1979