BIODEX,MODEL B-2000
Device Facts
| Record ID | K913021 |
|---|---|
| Device Name | BIODEX,MODEL B-2000 |
| Applicant | Biodex Corp. |
| Product Code | IKK · Physical Medicine |
| Decision Date | Oct 3, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1925 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
