Conductive Gel
FDA 510(k) K222770 · Top-Rank Health Care Co., Ltd.
510(k) numberK222770
Submission
- Device name
- Conductive Gel
- Applicant
- Top-Rank Health Care Co., Ltd.
Shaoxing, CN - Received
- September 14, 2022
- Decision date
- December 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243749 | Jmoon Conductive GelGYB · Traditional | Shenzhen Ulike Smart Electronics Co., Ltd. | 04/08/2025SE |
| K220735 | Avologi Gel Primer (Model: Av25)GYB · Traditional | Premier North America, Inc. | 09/15/2023SE |
| K221724 | Conductive GelGYB · Traditional | Tone-A-Matic International, Inc. | 09/23/2022SE |
| K212325 | EEG-acpGYB · Traditional | Somnomedics GmbH | 06/15/2022SE |
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| K212787 | GT5 conductive & abrasive gelGYB · Traditional | Wuhan Greentek Pty , Ltd. | 11/08/2021SE |
| K200402 | DR-HO'S Electro Therapy Conductive GelGYB · Traditional | Guangzhou Xinbo Electronic Co., Ltd. | 11/25/2020SE |
| K191975 | Elefix V Paste for EEG & EMGGYB · Traditional | Nihon Kohden Corporation | 02/07/2020SE |
| K192606 | SAC2 - Electrode CreamGYB · Traditional | Spes Medica Srl | 01/17/2020SE |
| K190050 | Tech Dots - Adhesive and conductive gelGYB · Traditional | Spes Medica Srl | 07/19/2019SE |
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Questions and answers
When was Conductive Gel cleared by the FDA?
Conductive Gel (K222770) received a 510(k) decision of Substantially Equivalent on December 13, 2022, 90 days after the submission was received.
What is the product code of K222770?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.