FDA Product Code
FDA Product Code IKK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.1925
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123746 | AMES THERAPY DEVICE | Ames Technology, Inc. | 2013-05-24 | Traditional | PDF ↗ |
| K952090 | HUMAC SYSTEM | Computer Sports Medicine, Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | Biodex Medical Systems, Inc. | 1995-11-16 | Traditional | PDF ↗ |
| K951916 | CC RIDER, MODEL ME180 | Mettler Electronics Corp. | 1995-10-04 | Traditional | PDF ↗ |
| K950095 | CYBEX 770 | Cybex | 1995-06-21 | Traditional | PDF ↗ |
| K942229 | MOTIVATOR FTR 2000 | Hogan & Hartson | 1995-02-27 | Traditional | PDF ↗ |
| K944732 | DEXTER ISOKINETIC | Cedaron Medical, Inc. | 1995-02-03 | Traditional | PDF ↗ |
| K924414 | THE BTE DYNAMIC LIFT | Baltimore Therapeutic Equipment Co. | 1993-02-12 | Traditional | PDF ↗ |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Biodan Medical Systems, Ltd. | 1992-07-23 | Traditional | PDF ↗ |
| K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | Biodan Medical Systems, Ltd. | 1992-07-13 | Traditional | PDF ↗ |
| K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | Biodan Medical Systems, Ltd. | 1992-05-26 | Traditional | PDF ↗ |
| K915144 | DEXTER HAND EVALUATION AND THERAPY SYSTEM | Cedars Medical Center | 1992-04-02 | Traditional | PDF ↗ |
| K915846 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | 1992-01-13 | Traditional | PDF ↗ |
| K915648 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | 1992-01-09 | Traditional | PDF ↗ |
| K913021 | BIODEX,MODEL B-2000 | Biodex Corp. | 1991-10-03 | Traditional | PDF ↗ |
| K913020 | BIODEX SYSTEM 2,MODEL S2-S | Biodex Corp. | 1991-10-03 | Traditional | PDF ↗ |
| K911666 | MEDX MACHINE | Medx Corp. | 1991-07-03 | Traditional | PDF ↗ |
| K911805 | KIN-COM ASYMMETRICAL BACK SYSTEM | Chattanooga Group, Inc. | 1991-07-03 | Traditional | PDF ↗ |
| K905525 | CYBEX 6000 | Cybex | 1991-02-14 | Traditional | PDF ↗ |
| K904898 | TORQUE FRAME QTF1000 | Medmetric Corp. | 1990-11-28 | Traditional | PDF ↗ |
| K901566 | PROMATRON 3000 | Promatek Medical Systems, Inc. | 1990-10-29 | Traditional | PDF ↗ |
| K903429 | LIDO LINEA | Loredan Biomedical, Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K902219 | KRONAMAX HUMAN PERFORMANCE LAB | Physicians Digital Co. | 1990-07-25 | Traditional | PDF ↗ |
| K900450 | BIODEX LIFT SIMULATOR | Biodex Corp. | 1990-07-24 | Traditional | PDF ↗ |
| K881676 | LINEAR LIFT DEVICE | Cybex | 1990-04-25 | Traditional | PDF ↗ |
| K881681 | CYBEX BACK TESTING AND REHABILITATION SYSTEM | Cybex | 1990-04-25 | Traditional | PDF ↗ |
| K900741 | BIODEX BACK SYSTEM ATTACHMENT | Biodex Corp. | 1990-02-26 | Traditional | PDF ↗ |
| K896553 | MEDX CERVICAL EXTENSION TEST & REHAB MACHINE | Medx Corp. | 1990-01-02 | Traditional | PDF ↗ |
| K894662 | TEST ONE | Primed Products, Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K895398 | BIO-COORDINATOR SYSTEM | Bio-Harmonizer, Inc. | 1989-09-28 | Traditional | PDF ↗ |
| K895236 | MEDX REHABILITATION MACHINE | Medx Corp. | 1989-09-14 | Traditional | PDF ↗ |
| K884487 | LIDO TM ACTIVE BACK | Loredan Biomedical, Inc. | 1988-11-18 | Traditional | PDF ↗ |
| K873659 | MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO | Universal Gym Equipment, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K880230 | SIXALYZER | Lukens Corp. | 1988-03-16 | Traditional | PDF ↗ |
| K880017 | LIDO(TM) LIFT | Loredan Biomedical, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K880018 | LIDO(TM) WORKSET | Loredan Biomedical, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K875235 | ISOKINETIC SYSTEM, TESTING AND EVALUATION | Orthopedic Systems, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K872911 | CYBEX 340 | Cybex | 1987-09-24 | Traditional | PDF ↗ |
| K871557 | DISCIPLINE II RTD | Physio Systems, Inc. | 1987-08-26 | Traditional | PDF ↗ |
| K872199 | DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER | Dyno-Max Co. | 1987-08-21 | Traditional | PDF ↗ |
| K871793 | LIDO ACTIVE | Loredan Biomedical, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K863313 | GRIP STRENGTH DEVICE (GSD) | Devcom, Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K862996 | PORTABLE ISOKINETICS 3004 KNEE UNIT | Kent Design & Manufacturing, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K862994 | PORTABLE ISOKINETICS 3002 ISO KANE II | Kent Design & Manufacturing, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K862997 | PORTABLE ISOKINETICS 3005 HIP UNIT | Kent Design & Manufacturing, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K862993 | PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT | Kent Design & Manufacturing, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K862995 | PORTABLE ISOKINETICS 3003 SHOULDER UNIT | Kent Design & Manufacturing, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K862998 | PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT | Kent Design & Manufacturing, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K862780 | TRU-KINETICS (TM) | Tru-Trac | 1986-08-04 | Traditional | PDF ↗ |
| K862096 | STATIC STRENGTH TESTER | Lowcountry Orthopaedic Assoc., P.A. | 1986-07-15 | Traditional | PDF ↗ |
| K861986 | LIDO BACK | Loredan Biomedical, Inc. | 1986-06-02 | Traditional | PDF ↗ |
| K861622 | SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER | Orthopedic Systems, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K861632 | SIMS CHAIR | Twin City Surgical, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K861206 | NAUTILUS LEG EXTENSION TESTING & REHABILITATION | Nautilus Sports/Medical Industries, Inc. | 1986-04-18 | Traditional | PDF ↗ |
| K860821 | BIODEX SYSTEM | Biodex Corp. | 1986-04-18 | Traditional | PDF ↗ |
| K844368 | LINEAR LIFT DEVICE | Cybex | 1985-02-19 | Traditional | PDF ↗ |
| K843739 | CYBEX TORSO TESTING & REHABILITATION | Cybex | 1984-11-29 | Traditional | PDF ↗ |
| K844060 | ISOSTATION ANKLE/SUBTALAR MACHINE A-100 | Isotechnologies, Inc. | 1984-11-23 | Traditional | PDF ↗ |
| K842296 | ISOSTATION LOWER BACK MACHINE | Isotechnologies, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K841849 | ISOSTATION SHOULDER MACHINE | Isotechnologies, Inc. | 1984-05-14 | Traditional | PDF ↗ |
| K832770 | LANE ONE | Loredan Biomedical, Inc. | 1983-09-26 | Traditional | PDF ↗ |
Product code IKK · Class II · Physical Medicine. Data: openFDA.