← Product Code [GWY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY) · K780422

# PINWHEEL (K780422)

_Projects IN Health · GWY · Apr 4, 1978 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K780422

## Device Facts

- **Applicant:** Projects IN Health
- **Product Code:** [GWY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY.md)
- **Decision Date:** Apr 4, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1750
- **Device Class:** Class 1
- **Review Panel:** Neurology

## Regulatory Identification

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

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K780422](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWY/K780422)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com