Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1750](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1750) → GWY — Pinwheel

# GWY · Pinwheel

_Neurology · 21 CFR 882.1750 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY

## Overview

- **Product Code:** GWY
- **Device Name:** Pinwheel
- **Regulation:** [21 CFR 882.1750](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1750)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050313](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K050313.md) | BIS SRS (SEMI-RESUABLE SENSOR) | Aspect Medical Systems, Inc. | Feb 24, 2005 | SESE |
| [K942926](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K942926.md) | NEURO-AIDE | Burke Neutech, Inc. | Aug 3, 1994 | SESE |
| [K871167](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K871167.md) | SENSITESTER | Dexin Pty. , Ltd. | Apr 1, 1987 | SESE |
| [K851749](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K851749.md) | 1-380 PINWHEEL (WARTENBERG) | Artiberia | Jun 13, 1985 | SESE |
| [K780422](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K780422.md) | PINWHEEL | Projects IN Health | Apr 4, 1978 | SESE |

## Top Applicants

- Artiberia — 1 clearance
- Aspect Medical Systems, Inc. — 1 clearance
- Burke Neutech, Inc. — 1 clearance
- Dexin Pty. , Ltd. — 1 clearance
- Projects IN Health — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY)

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