IKK — System, Isokinetic Testing And Evaluation Class II
FDA product code IKK covers "System, Isokinetic Testing And Evaluation", a Class II medical device regulated under 21 CFR 890.1925. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IKK
- Device Class
- Class II
- Regulation Number
- 890.1925
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123746 | ames technology | AMES THERAPY DEVICE | May 24, 2013 |
| K952090 | computer sports medicine | HUMAC SYSTEM | December 11, 1995 |
| K951770 | biodex medical systems | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | November 16, 1995 |
| K951916 | mettler electronics | CC RIDER, MODEL ME180 | October 4, 1995 |
| K950095 | cybex | CYBEX 770 | June 21, 1995 |
| K942229 | hogan and hartson | MOTIVATOR FTR 2000 | February 27, 1995 |
| K944732 | cedaron medical | DEXTER ISOKINETIC | February 3, 1995 |
| K924414 | baltimore therapeutic equipment | THE BTE DYNAMIC LIFT | February 12, 1993 |
| K923350 | biodan medical systems | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | July 23, 1992 |
| K922772 | biodan medical systems | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | July 13, 1992 |
| K922092 | biodan medical systems | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | May 26, 1992 |
| K915144 | cedars medical center | DEXTER HAND EVALUATION AND THERAPY SYSTEM | April 2, 1992 |
| K915846 | biodex | BIODEX SYSTEM 2 AUTOPROGRAM | January 13, 1992 |
| K915648 | biodex | BIODEX SYSTEM 2 AUTOPROGRAM | January 9, 1992 |
| K913020 | biodex | BIODEX SYSTEM 2,MODEL S2-S | October 3, 1991 |
| K913021 | biodex | BIODEX,MODEL B-2000 | October 3, 1991 |
| K911666 | medx | MEDX MACHINE | July 3, 1991 |
| K911805 | chattanooga group | KIN-COM ASYMMETRICAL BACK SYSTEM | July 3, 1991 |
| K905525 | cybex | CYBEX 6000 | February 14, 1991 |
| K904898 | medmetric | TORQUE FRAME QTF1000 | November 28, 1990 |