Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart B — Physical Medicine Diagnostic Devices](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices) → [21 CFR 890.1450](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1450) → IKO — Hammer, Reflex, Powered

# IKO · Hammer, Reflex, Powered

_Physical Medicine · 21 CFR 890.1450 · Class 2_

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

## Overview

- **Product Code:** IKO
- **Device Name:** Hammer, Reflex, Powered
- **Regulation:** [21 CFR 890.1450](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1450)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

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

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K904113](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKO/K904113.md) | OPERATIVE RECORDING CAMERA | Medical Dynamics, Inc. | Oct 30, 1990 | SESE |

## Top Applicants

- Medical Dynamics, Inc. — 1 clearance

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

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