Atlas FDA

IKK

61 FDA 510(k) clearances · Product code

45 daysmedian time to decision
209 days90th percentile
61clearances measured

FDA profile

Official device name
System, Isokinetic Testing And Evaluation
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1925
Medical specialty
Physical Medicine
Adverse events (MAUDE)
1994: 2 · 1995: 1 · 1996: 1 · 1997: 2 · 1998: 2 · 1999: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AMES THERAPY DEVICE (K123746)Ames Technology, Inc.2013-05-24
HUMAC SYSTEM (K952090)Computer Sports Medicine, Inc.1995-12-11
BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (K951770)Biodex Medical Systems, Inc.1995-11-16
CC RIDER, MODEL ME180 (K951916)Mettler Electronics Corp.1995-10-04
CYBEX 770 (K950095)Cybex1995-06-21
MOTIVATOR FTR 2000 (K942229)Hogan & Hartson1995-02-27
DEXTER ISOKINETIC (K944732)Cedaron Medical, Inc.1995-02-03
THE BTE DYNAMIC LIFT (K924414)Baltimore Therapeutic Equipment Co.1993-02-12
CLOSED CHAIN ATTACHMENT, MODEL #820-520 (K923350)Biodan Medical Systems, Ltd.1992-07-23
TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (K922772)Biodan Medical Systems, Ltd.1992-07-13
SINGLE CHAIR INTEGRAL BACK ATTACHMENT (K922092)Biodan Medical Systems, Ltd.1992-05-26
DEXTER HAND EVALUATION AND THERAPY SYSTEM (K915144)Cedars Medical Center1992-04-02
BIODEX SYSTEM 2 AUTOPROGRAM (K915846)Biodex Corp.1992-01-13
BIODEX SYSTEM 2 AUTOPROGRAM (K915648)Biodex Corp.1992-01-09
BIODEX,MODEL B-2000 (K913021)Biodex Corp.1991-10-03
BIODEX SYSTEM 2,MODEL S2-S (K913020)Biodex Corp.1991-10-03
KIN-COM ASYMMETRICAL BACK SYSTEM (K911805)Chattanooga Group, Inc.1991-07-03
MEDX MACHINE (K911666)Medx Corp.1991-07-03
CYBEX 6000 (K905525)Cybex1991-02-14
TORQUE FRAME QTF1000 (K904898)Medmetric Corp.1990-11-28
PROMATRON 3000 (K901566)Promatek Medical Systems, Inc.1990-10-29
LIDO LINEA (K903429)Loredan Biomedical, Inc.1990-08-14
KRONAMAX HUMAN PERFORMANCE LAB (K902219)Physicians Digital Co.1990-07-25
BIODEX LIFT SIMULATOR (K900450)Biodex Corp.1990-07-24
CYBEX BACK TESTING AND REHABILITATION SYSTEM (K881681)Cybex1990-04-25
LINEAR LIFT DEVICE (K881676)Cybex1990-04-25
BIODEX BACK SYSTEM ATTACHMENT (K900741)Biodex Corp.1990-02-26
MEDX CERVICAL EXTENSION TEST & REHAB MACHINE (K896553)Medx Corp.1990-01-02
TEST ONE (K894662)Primed Products, Inc.1989-12-13
BIO-COORDINATOR SYSTEM (K895398)Bio-Harmonizer, Inc.1989-09-28
MEDX REHABILITATION MACHINE (K895236)Medx Corp.1989-09-14
LIDO TM ACTIVE BACK (K884487)Loredan Biomedical, Inc.1988-11-18
MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO (K873659)Universal Gym Equipment, Inc.1988-04-21
SIXALYZER (K880230)Lukens Corp.1988-03-16
LIDO(TM) LIFT (K880017)Loredan Biomedical, Inc.1988-02-26
LIDO(TM) WORKSET (K880018)Loredan Biomedical, Inc.1988-02-26
ISOKINETIC SYSTEM, TESTING AND EVALUATION (K875235)Orthopedic Systems, Inc.1988-01-19
CYBEX 340 (K872911)Cybex1987-09-24
DISCIPLINE II RTD (K871557)Physio Systems, Inc.1987-08-26
DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER (K872199)Dyno-Max Co.1987-08-21
LIDO ACTIVE (K871793)Loredan Biomedical, Inc.1987-06-05
GRIP STRENGTH DEVICE (GSD) (K863313)Devcom, Inc.1986-09-09
PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT (K862998)Kent Design & Manufacturing, Inc.1986-08-20
PORTABLE ISOKINETICS 3003 SHOULDER UNIT (K862995)Kent Design & Manufacturing, Inc.1986-08-20
PORTABLE ISOKINETICS 3002 ISO KANE II (K862994)Kent Design & Manufacturing, Inc.1986-08-20
PORTABLE ISOKINETICS 3004 KNEE UNIT (K862996)Kent Design & Manufacturing, Inc.1986-08-20
PORTABLE ISOKINETICS 3005 HIP UNIT (K862997)Kent Design & Manufacturing, Inc.1986-08-20
PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT (K862993)Kent Design & Manufacturing, Inc.1986-08-20
TRU-KINETICS (TM) (K862780)Tru-Trac1986-08-04
STATIC STRENGTH TESTER (K862096)Lowcountry Orthopaedic Assoc., P.A.1986-07-15
LIDO BACK (K861986)Loredan Biomedical, Inc.1986-06-02
SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER (K861622)Orthopedic Systems, Inc.1986-05-27
SIMS CHAIR (K861632)Twin City Surgical, Inc.1986-05-27
BIODEX SYSTEM (K860821)Biodex Corp.1986-04-18
NAUTILUS LEG EXTENSION TESTING & REHABILITATION (K861206)Nautilus Sports/Medical Industries, Inc.1986-04-18
LINEAR LIFT DEVICE (K844368)Cybex1985-02-19
CYBEX TORSO TESTING & REHABILITATION (K843739)Cybex1984-11-29
ISOSTATION ANKLE/SUBTALAR MACHINE A-100 (K844060)Isotechnologies, Inc.1984-11-23
ISOSTATION LOWER BACK MACHINE (K842296)Isotechnologies, Inc.1984-06-22
ISOSTATION SHOULDER MACHINE (K841849)Isotechnologies, Inc.1984-05-14
LANE ONE (K832770)Loredan Biomedical, Inc.1983-09-26

Track IKK automatically

Every clearance here is in the API, with alerts when new ones post.