IKK — System, Isokinetic Testing And Evaluation Class II

FDA Device Classification

Classification Details

Product Code
IKK
Device Class
Class II
Regulation Number
890.1925
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123746ames technologyAMES THERAPY DEVICEMay 24, 2013
K952090computer sports medicineHUMAC SYSTEMDecember 11, 1995
K951770biodex medical systemsBIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APNovember 16, 1995
K951916mettler electronicsCC RIDER, MODEL ME180October 4, 1995
K950095cybexCYBEX 770June 21, 1995
K942229hogan and hartsonMOTIVATOR FTR 2000February 27, 1995
K944732cedaron medicalDEXTER ISOKINETICFebruary 3, 1995
K924414baltimore therapeutic equipmentTHE BTE DYNAMIC LIFTFebruary 12, 1993
K923350biodan medical systemsCLOSED CHAIN ATTACHMENT, MODEL #820-520July 23, 1992
K922772biodan medical systemsTWO POSITION ROLL-UP BACK ATTACHMENT CHAIRJuly 13, 1992
K922092biodan medical systemsSINGLE CHAIR INTEGRAL BACK ATTACHMENTMay 26, 1992
K915144cedars medical centerDEXTER HAND EVALUATION AND THERAPY SYSTEMApril 2, 1992
K915846biodexBIODEX SYSTEM 2 AUTOPROGRAMJanuary 13, 1992
K915648biodexBIODEX SYSTEM 2 AUTOPROGRAMJanuary 9, 1992
K913020biodexBIODEX SYSTEM 2,MODEL S2-SOctober 3, 1991
K913021biodexBIODEX,MODEL B-2000October 3, 1991
K911805chattanooga groupKIN-COM ASYMMETRICAL BACK SYSTEMJuly 3, 1991
K911666medxMEDX MACHINEJuly 3, 1991
K905525cybexCYBEX 6000February 14, 1991
K904898medmetricTORQUE FRAME QTF1000November 28, 1990