Product code IKK— Physical Medicine
BIODEX SYSTEM 2 AUTOPROGRAM
- Classification name
- System, Isokinetic Testing And Evaluation
- Device class
- Class 2
- Regulation
- 21 CFR 890.1925
- Advisory panel
- Physical Medicine
- Total cleared
- 61
- First cleared
- Most recent
Market context for product code IKK
FDA has cleared devices under product code IKK between 1983 and 2013, filed by 31 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2013
- 1995
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
Top applicants under product code IKK
Recent clearances under product code IKK
- K123746 — AMES THERAPY DEVICE
- K952090 — HUMAC SYSTEM
- K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
- K951916 — CC RIDER, MODEL ME180
- K950095 — CYBEX 770
- K942229 — MOTIVATOR FTR 2000
- K944732 — DEXTER ISOKINETIC
- K924414 — THE BTE DYNAMIC LIFT
- K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520
- K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR
- K922092 — SINGLE CHAIR INTEGRAL BACK ATTACHMENT
- K915144 — DEXTER HAND EVALUATION AND THERAPY SYSTEM
- K915846 — BIODEX SYSTEM 2 AUTOPROGRAM
- K915648 — BIODEX SYSTEM 2 AUTOPROGRAM
- K913020 — BIODEX SYSTEM 2,MODEL S2-S
- K913021 — BIODEX,MODEL B-2000
- K911666 — MEDX MACHINE
- K911805 — KIN-COM ASYMMETRICAL BACK SYSTEM
- K905525 — CYBEX 6000
- K904898 — TORQUE FRAME QTF1000
- K901566 — PROMATRON 3000
- K903429 — LIDO LINEA
- K902219 — KRONAMAX HUMAN PERFORMANCE LAB
- K900450 — BIODEX LIFT SIMULATOR
- K881676 — LINEAR LIFT DEVICE
- K881681 — CYBEX BACK TESTING AND REHABILITATION SYSTEM
- K900741 — BIODEX BACK SYSTEM ATTACHMENT
- K896553 — MEDX CERVICAL EXTENSION TEST & REHAB MACHINE
- K894662 — TEST ONE
- K895398 — BIO-COORDINATOR SYSTEM
- K895236 — MEDX REHABILITATION MACHINE
- K884487 — LIDO TM ACTIVE BACK
- K873659 — MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO
- K880230 — SIXALYZER
- K880017 — LIDO(TM) LIFT
- K880018 — LIDO(TM) WORKSET
- K875235 — ISOKINETIC SYSTEM, TESTING AND EVALUATION
- K872911 — CYBEX 340
- K871557 — DISCIPLINE II RTD
- K872199 — DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER
- K871793 — LIDO ACTIVE
- K863313 — GRIP STRENGTH DEVICE (GSD)
- K862993 — PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT
- K862994 — PORTABLE ISOKINETICS 3002 ISO KANE II
- K862995 — PORTABLE ISOKINETICS 3003 SHOULDER UNIT
- K862996 — PORTABLE ISOKINETICS 3004 KNEE UNIT
- K862997 — PORTABLE ISOKINETICS 3005 HIP UNIT
- K862998 — PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT
- K862780 — TRU-KINETICS (TM)
- K862096 — STATIC STRENGTH TESTER
- K861986 — LIDO BACK
- K861622 — SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER
- K861632 — SIMS CHAIR
- K860821 — BIODEX SYSTEM
- K861206 — NAUTILUS LEG EXTENSION TESTING & REHABILITATION
- K844368 — LINEAR LIFT DEVICE
- K843739 — CYBEX TORSO TESTING & REHABILITATION
- K844060 — ISOSTATION ANKLE/SUBTALAR MACHINE A-100
- K842296 — ISOSTATION LOWER BACK MACHINE
- K841849 — ISOSTATION SHOULDER MACHINE
- K832770 — LANE ONE
Data sourced from openFDA. This site is unofficial and independent of the FDA.