← Product Code [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN) · K791235

# CADWELL 7000 ELECTROMYOGRAPH MACHINE (K791235)

_Cadwell Laboratories, Inc. · IKN · Aug 16, 1979 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K791235

## Device Facts

- **Applicant:** Cadwell Laboratories, Inc.
- **Product Code:** [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN.md)
- **Decision Date:** Aug 16, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1375
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K791235](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K791235)

**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