← Product Code [IKK](/productcode/IKK) · K881681

# CYBEX BACK TESTING AND REHABILITATION SYSTEM (K881681)

_Cybex · IKK · Apr 25, 1990 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K881681

## Device Facts

- **Applicant:** Cybex
- **Product Code:** [IKK](/productcode/IKK.md)
- **Decision Date:** Apr 25, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1925
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory 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.

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**Source:** [https://fda-staging.innolitics.com/device/K881681](https://fda-staging.innolitics.com/device/K881681)

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