Panels › Physical Medicine › Product code IKK · Class 2
System, Isokinetic Testing And Evaluation
Regulation 890.1925
0510(k)s in 12 months (61 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in IKK
| Company | 510(k)s | Recalls |
|---|---|---|
| Biodex Corp. | 7 | 0 |
| Cybex | 7 | 0 |
| Loredan Biomedical, Inc. | 7 | 0 |
| Kent Design & Manufacturing, Inc. | 6 | 0 |
| Biodan Medical Systems, Ltd. | 3 | 0 |
| Isotechnologies, Inc. | 3 | 0 |
| Medx Corp. | 3 | 0 |
| Orthopedic Systems, Inc. | 2 | 0 |
| Ames Technology, Inc. | 1 | 0 |
| Baltimore Therapeutic Equipment Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2013 | K123746 | AMES THERAPY DEVICE Ames Technology, Inc. | IKK |
| Dec 11, 1995 | K952090 | HUMAC SYSTEM Computer Sports Medicine, Inc. | IKK |
| Nov 16, 1995 | K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP Biodex Medical Systems, Inc. | IKK |
| Oct 4, 1995 | K951916 | CC RIDER, MODEL ME180 Mettler Electronics Corp. | IKK |
| Jun 21, 1995 | K950095 | CYBEX 770 Cybex | IKK |
| Feb 27, 1995 | K942229 | MOTIVATOR FTR 2000 Hogan & Hartson | IKK |
| Feb 3, 1995 | K944732 | DEXTER ISOKINETIC Cedaron Medical, Inc. | IKK |
| Feb 12, 1993 | K924414 | THE BTE DYNAMIC LIFT Baltimore Therapeutic Equipment Co. | IKK |
| Jul 23, 1992 | K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 Biodan Medical Systems, Ltd. | IKK |
| Jul 13, 1992 | K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR Biodan Medical Systems, Ltd. | IKK |
| May 26, 1992 | K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT Biodan Medical Systems, Ltd. | IKK |
| Apr 2, 1992 | K915144 | DEXTER HAND EVALUATION AND THERAPY SYSTEM Cedars Medical Center | IKK |
| Jan 13, 1992 | K915846 | BIODEX SYSTEM 2 AUTOPROGRAM Biodex Corp. | IKK |
| Jan 9, 1992 | K915648 | BIODEX SYSTEM 2 AUTOPROGRAM Biodex Corp. | IKK |
| Oct 3, 1991 | K913021 | BIODEX,MODEL B-2000 Biodex Corp. | IKK |
| Oct 3, 1991 | K913020 | BIODEX SYSTEM 2,MODEL S2-S Biodex Corp. | IKK |
| Jul 3, 1991 | K911805 | KIN-COM ASYMMETRICAL BACK SYSTEM Chattanooga Group, Inc. | IKK |
| Jul 3, 1991 | K911666 | MEDX MACHINE Medx Corp. | IKK |
| Feb 14, 1991 | K905525 | CYBEX 6000 Cybex | IKK |
| Nov 28, 1990 | K904898 | TORQUE FRAME QTF1000 Medmetric Corp. | IKK |
| Oct 29, 1990 | K901566 | PROMATRON 3000 Promatek Medical Systems, Inc. | IKK |
| Aug 14, 1990 | K903429 | LIDO LINEA Loredan Biomedical, Inc. | IKK |
| Jul 25, 1990 | K902219 | KRONAMAX HUMAN PERFORMANCE LAB Physicians Digital Co. | IKK |
| Jul 24, 1990 | K900450 | BIODEX LIFT SIMULATOR Biodex Corp. | IKK |
| Apr 25, 1990 | K881681 | CYBEX BACK TESTING AND REHABILITATION SYSTEM Cybex | IKK |
| Apr 25, 1990 | K881676 | LINEAR LIFT DEVICE Cybex | IKK |
| Feb 26, 1990 | K900741 | BIODEX BACK SYSTEM ATTACHMENT Biodex Corp. | IKK |
| Jan 2, 1990 | K896553 | MEDX CERVICAL EXTENSION TEST & REHAB MACHINE Medx Corp. | IKK |
| Dec 13, 1989 | K894662 | TEST ONE Primed Products, Inc. | IKK |
| Sep 28, 1989 | K895398 | BIO-COORDINATOR SYSTEM Bio-Harmonizer, Inc. | IKK |
| Sep 14, 1989 | K895236 | MEDX REHABILITATION MACHINE Medx Corp. | IKK |
| Nov 18, 1988 | K884487 | LIDO TM ACTIVE BACK Loredan Biomedical, Inc. | IKK |
| Apr 21, 1988 | K873659 | MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO Universal Gym Equipment, Inc. | IKK |
| Mar 16, 1988 | K880230 | SIXALYZER Lukens Corp. | IKK |
| Feb 26, 1988 | K880018 | LIDO(TM) WORKSET Loredan Biomedical, Inc. | IKK |
| Feb 26, 1988 | K880017 | LIDO(TM) LIFT Loredan Biomedical, Inc. | IKK |
| Jan 19, 1988 | K875235 | ISOKINETIC SYSTEM, TESTING AND EVALUATION Orthopedic Systems, Inc. | IKK |
| Sep 24, 1987 | K872911 | CYBEX 340 Cybex | IKK |
| Aug 26, 1987 | K871557 | DISCIPLINE II RTD Physio Systems, Inc. | IKK |
| Aug 21, 1987 | K872199 | DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER Dyno-Max Co. | IKK |
| Jun 5, 1987 | K871793 | LIDO ACTIVE Loredan Biomedical, Inc. | IKK |
| Sep 9, 1986 | K863313 | GRIP STRENGTH DEVICE (GSD) Devcom, Inc. | IKK |
| Aug 20, 1986 | K862998 | PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT Kent Design & Manufacturing, Inc. | IKK |
| Aug 20, 1986 | K862997 | PORTABLE ISOKINETICS 3005 HIP UNIT Kent Design & Manufacturing, Inc. | IKK |
| Aug 20, 1986 | K862996 | PORTABLE ISOKINETICS 3004 KNEE UNIT Kent Design & Manufacturing, Inc. | IKK |
| Aug 20, 1986 | K862995 | PORTABLE ISOKINETICS 3003 SHOULDER UNIT Kent Design & Manufacturing, Inc. | IKK |
| Aug 20, 1986 | K862994 | PORTABLE ISOKINETICS 3002 ISO KANE II Kent Design & Manufacturing, Inc. | IKK |
| Aug 20, 1986 | K862993 | PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT Kent Design & Manufacturing, Inc. | IKK |
| Aug 4, 1986 | K862780 | TRU-KINETICS (TM) Tru-Trac | IKK |
| Jul 15, 1986 | K862096 | STATIC STRENGTH TESTER Lowcountry Orthopaedic Assoc., P.A. | IKK |
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