← Product Code [IKK](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK) · K952090

# HUMAC SYSTEM (K952090)

_Computer Sports Medicine, Inc. · IKK · Dec 11, 1995 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K952090

## Device Facts

- **Applicant:** Computer Sports Medicine, Inc.
- **Product Code:** [IKK](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK.md)
- **Decision Date:** Dec 11, 1995
- **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.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K952090](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKK/K952090)

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