← Product Code [IKO](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKO) · K904113

# OPERATIVE RECORDING CAMERA (K904113)

_Medical Dynamics, Inc. · IKO · Oct 30, 1990 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKO/K904113

## Device Facts

- **Applicant:** Medical Dynamics, Inc.
- **Product Code:** [IKO](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKO.md)
- **Decision Date:** Oct 30, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1450
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes.

## 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 the limitations in § 890.9.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKO/K904113](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKO/K904113)

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