← Product Code [HOW](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOW) · K822917

# MODEL 5400 OPTOKINETIC STIMULATOR (K822917)

_Life-Tech Intl., Inc. · HOW · Nov 1, 1982 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOW/K822917

## Device Facts

- **Applicant:** Life-Tech Intl., Inc.
- **Product Code:** [HOW](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOW.md)
- **Decision Date:** Nov 1, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1200
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOW/K822917](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HOW/K822917)

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