IKK · System, Isokinetic Testing And Evaluation
Physical Medicine · 21 CFR 890.1925 · Class 2
Overview
| Product Code | IKK |
|---|---|
| Device Name | System, Isokinetic Testing And Evaluation |
| Regulation | 21 CFR 890.1925 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123746 | AMES THERAPY DEVICE | Ames Technology, Inc. | May 24, 2013 | SESE |
| K952090 | HUMAC SYSTEM | Computer Sports Medicine, Inc. | Dec 11, 1995 | SESE |
| K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | Biodex Medical Systems, Inc. | Nov 16, 1995 | SESE |
| K951916 | CC RIDER, MODEL ME180 | Mettler Electronics Corp. | Oct 4, 1995 | SESE |
| K950095 | CYBEX 770 | Cybex | Jun 21, 1995 | SESE |
| K942229 | MOTIVATOR FTR 2000 | Hogan & Hartson | Feb 27, 1995 | SESE |
| K944732 | DEXTER ISOKINETIC | Cedaron Medical, Inc. | Feb 3, 1995 | SESE |
| K924414 | THE BTE DYNAMIC LIFT | Baltimore Therapeutic Equipment Co. | Feb 12, 1993 | SESE |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Biodan Medical Systems, Ltd. | Jul 23, 1992 | SESE |
| K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | Biodan Medical Systems, Ltd. | Jul 13, 1992 | SESE |
| K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | Biodan Medical Systems, Ltd. | May 26, 1992 | SESE |
| K915144 | DEXTER HAND EVALUATION AND THERAPY SYSTEM | Cedars Medical Center | Apr 2, 1992 | SESE |
| K915846 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | Jan 13, 1992 | SESE |
| K915648 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | Jan 9, 1992 | SESE |
| K913021 | BIODEX,MODEL B-2000 | Biodex Corp. | Oct 3, 1991 | SESE |
| K913020 | BIODEX SYSTEM 2,MODEL S2-S | Biodex Corp. | Oct 3, 1991 | SESE |
| K911805 | KIN-COM ASYMMETRICAL BACK SYSTEM | Chattanooga Group, Inc. | Jul 3, 1991 | SESE |
| K911666 | MEDX MACHINE | Medx Corp. | Jul 3, 1991 | SESE |
| K905525 | CYBEX 6000 | Cybex | Feb 14, 1991 | SESE |
| K904898 | TORQUE FRAME QTF1000 | Medmetric Corp. | Nov 28, 1990 | SESE |
Top Applicants
- Biodex Corp. — 7 clearances
- Cybex — 7 clearances
- Loredan Biomedical, Inc. — 7 clearances
- Kent Design & Manufacturing, Inc. — 6 clearances
- Biodan Medical Systems, Ltd. — 3 clearances
