Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1200](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1200) → GWI — Discriminator, Two-Point

# GWI · Discriminator, Two-Point

_Neurology · 21 CFR 882.1200 · Class 1_

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

## Overview

- **Product Code:** GWI
- **Device Name:** Discriminator, Two-Point
- **Regulation:** [21 CFR 882.1200](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1200)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)
- **GMP exempt:** yes

## Identification

A two-point discriminator is a device with points used for testing a patient's touch discrimination.

## 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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K944234](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWI/K944234.md) | TCD OR TCD NEUROPATHY STAR | Jcm Management & Planning Co. | Mar 8, 1995 | SESE |
| [K874300](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWI/K874300.md) | AESTHESIOMETER | Orthopedic Systems, Inc. | Nov 6, 1987 | SESE |

## Top Applicants

- Jcm Management & Planning Co. — 1 clearance
- Orthopedic Systems, Inc. — 1 clearance

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

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