Nissha Medical Technologies Neutral Electrodes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203494 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Neutral electrodes are grounding pads used to provide a secure electrical return path during diathermy and other high‑frequency surgical or therapeutic procedures. They are designed to maintain complete contact with the patient’s skin, ensuring effective and safe electrical grounding.
The device is cleared under FDA 510(k) (K203494) with product code GEI and is supplied by Nissha Medical Technologies Ltd, United Kingdom. It is listed as a traditional clearance and was received on 27 Nov 2020 with a decision date of 23 Feb 2021. The electrodes are provided as a medical device product and are subject to the applicable regulatory requirements indicated in the submission.
Frequently asked questions
What clinical purpose do Nissha neutral electrodes serve?
They are grounding pads that create a secure electrical return path during diathermy and other high‑frequency surgical or therapeutic procedures, ensuring continuous skin contact for effective and safe electrical grounding.
How are the neutral electrodes supplied to the user?
The electrodes are supplied as a medical device product by Nissha Medical Technologies Ltd in the United Kingdom. They are provided as a finished grounding pad ready for use in the operating or treatment setting.
Are the electrodes sterile or intended for single‑use?
The device description does not specify sterility or single‑use status, so users should refer to the manufacturer’s labeling or packaging for those details before clinical use.
What regulatory clearance do these electrodes have?
The neutral electrodes are cleared under FDA 510(k) (K203494) with product code GEI, indicating they were found substantially equivalent to a predicate device and received traditional clearance on 23 Feb 2021.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Grounding Pads, Diathermy Pads / Neutral Electrodes - Nissha, Grounding Pads and Neutral Electrodes from Nissha Medical Technologies, Nissha Medical Technologies | Medical Products, Nissha Medical Technologies | Medical Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203494 | Class II | Active |
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Manufacturer
- Manufacturer
- Nissha Medical Technologies Ltd
- FDA Applicant
- Nissha Medical Technologies, Ltd.
Sources (1)
- FDA 510(k) K203494 24 fields · synced Sep 28, 2026