Product code IKK
- Device name
- System, Isokinetic Testing And Evaluation
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.1925
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123746 | AMES THERAPY DEVICE | Ames Technology, Inc. | 2013-05-24 |
| K952090 | HUMAC SYSTEM | Computer Sports Medicine, Inc. | 1995-12-11 |
| K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | Biodex Medical Systems, Inc. | 1995-11-16 |
| K951916 | CC RIDER, MODEL ME180 | Mettler Electronics Corp. | 1995-10-04 |
| K950095 | CYBEX 770 | Cybex | 1995-06-21 |
| K942229 | MOTIVATOR FTR 2000 | Hogan & Hartson | 1995-02-27 |
| K944732 | DEXTER ISOKINETIC | Cedaron Medical, Inc. | 1995-02-03 |
| K924414 | THE BTE DYNAMIC LIFT | Baltimore Therapeutic Equipment Co. | 1993-02-12 |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Biodan Medical Systems, Ltd. | 1992-07-23 |
| K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | Biodan Medical Systems, Ltd. | 1992-07-13 |
| K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | Biodan Medical Systems, Ltd. | 1992-05-26 |
| K915144 | DEXTER HAND EVALUATION AND THERAPY SYSTEM | Cedars Medical Center | 1992-04-02 |
| K915846 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | 1992-01-13 |
| K915648 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | 1992-01-09 |
| K913021 | BIODEX,MODEL B-2000 | Biodex Corp. | 1991-10-03 |
| K913020 | BIODEX SYSTEM 2,MODEL S2-S | Biodex Corp. | 1991-10-03 |
| K911805 | KIN-COM ASYMMETRICAL BACK SYSTEM | Chattanooga Group, Inc. | 1991-07-03 |
| K911666 | MEDX MACHINE | Medx Corp. | 1991-07-03 |
| K905525 | CYBEX 6000 | Cybex | 1991-02-14 |
| K904898 | TORQUE FRAME QTF1000 | Medmetric Corp. | 1990-11-28 |
| K901566 | PROMATRON 3000 | Promatek Medical Systems, Inc. | 1990-10-29 |
| K903429 | LIDO LINEA | Loredan Biomedical, Inc. | 1990-08-14 |
| K902219 | KRONAMAX HUMAN PERFORMANCE LAB | Physicians Digital Co. | 1990-07-25 |
| K900450 | BIODEX LIFT SIMULATOR | Biodex Corp. | 1990-07-24 |
| K881681 | CYBEX BACK TESTING AND REHABILITATION SYSTEM | Cybex | 1990-04-25 |
| K881676 | LINEAR LIFT DEVICE | Cybex | 1990-04-25 |
| K900741 | BIODEX BACK SYSTEM ATTACHMENT | Biodex Corp. | 1990-02-26 |
| K896553 | MEDX CERVICAL EXTENSION TEST & REHAB MACHINE | Medx Corp. | 1990-01-02 |
| K894662 | TEST ONE | Primed Products, Inc. | 1989-12-13 |
| K895398 | BIO-COORDINATOR SYSTEM | Bio-Harmonizer, Inc. | 1989-09-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06975343590140 | Lower extremity intelligent feedback training system for children | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590010 | Upper Limbs Intelligent Feedback and Training System | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590027 | Lower Limbs Intelligent Feedback and Training System | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590034 | Gait Training and Evaluation System | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590041 | Multi-joint isokinetic training and testing system | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590058 | Multi-joint isokinetic training and testing system | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590065 | Multi-joint isokinetic training and testing system | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590072 | Upper Limbs Training and Evaluation System | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590089 | Upper Limbs Training and Evaluation System | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 06975343590133 | Lower extremity intelligent feedback training system for children | Guangzhou Yikang Medical Equipment Industrial Co.,Ltd | 2026-05-14 |
| 04041925006360 | PHS - L | medica - Medizintechnik GmbH | 2026-05-13 |
| 04041925006377 | PHS - XL | medica - Medizintechnik GmbH | 2026-05-13 |
| 04041925006353 | PHS - M | medica - Medizintechnik GmbH | 2026-05-13 |
| 04041925006346 | PHS - S | medica - Medizintechnik GmbH | 2026-05-13 |
| 04041925006339 | PHS - XS | medica - Medizintechnik GmbH | 2026-05-13 |
| 00815962020634 | BITS Motion Sensor | BIONESS INC. | 2020-08-10 |
| 00815962020610 | Bioness Integrated Therapy System, BITS 3.0, BITS Balance | BIONESS INC. | 2020-08-10 |
| 10850390007366 | EVJ | BTE TECHNOLOGIES, INC. | 2020-05-12 |
| 00860001346701 | InMotion ARM | BIONIK, INC. | 2019-10-04 |
| 05060481691666 | DataLOG MWX8 | BIOMETRICS LIMITED | 2018-08-10 |
| 05060481692052 | DataLINK DLK900 | BIOMETRICS LIMITED | 2018-08-10 |
| 05060481691932 | DataLINK Management Software (Version 10) | BIOMETRICS LIMITED | 2018-08-10 |
| 05060481691680 | DataLOG Management + Analysis Software (Version 10) | BIOMETRICS LIMITED | 2018-08-10 |
| 05060481690867 | DataLITE Management + Analysis Software (Version 10) | BIOMETRICS LIMITED | 2018-08-10 |
| 05060481690850 | DataLITE Management Software (Version 10) | BIOMETRICS LIMITED | 2018-08-10 |
| 05060481692403 | Biometrics Ltd Dynamometer | BIOMETRICS LIMITED | 2018-08-09 |
| 05060481690607 | DataLITE DG2 Wireless Dongle | BIOMETRICS LIMITED | 2018-08-09 |
| 00190446286974 | DONJOY | DJO, LLC | 2018-04-17 |
| 00190446286967 | DONJOY | DJO, LLC | 2018-04-17 |
| 05060481690034 | Biometrics Ltd Pinchmeter | BIOMETRICS LIMITED | 2018-02-14 |