← Product Code [GYB](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB) · K820991

# KENZ-GELECT GEL PAD (K820991)

_Suzuken Co., Ltd. · GYB · Apr 26, 1982 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB/K820991

## Device Facts

- **Applicant:** Suzuken Co., Ltd.
- **Product Code:** [GYB](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB.md)
- **Decision Date:** Apr 26, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1275
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB/K820991](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB/K820991)

**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