DR-HO'S Electro Therapy Conductive Gel
FDA 510(k) K200402 · Guangzhou Xinbo Electronic Co., Ltd.
510(k) numberK200402
Submission
- Device name
- DR-HO'S Electro Therapy Conductive Gel
- Applicant
- Guangzhou Xinbo Electronic Co., Ltd.
Guangzhou, CN - Received
- February 19, 2020
- Decision date
- November 25, 2020
- 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 |
| K222770 | Conductive GelGYB · Traditional | Top-Rank Health Care Co., Ltd. | 12/13/2022SE |
| K221724 | Conductive GelGYB · Traditional | Tone-A-Matic International, Inc. | 09/23/2022SE |
| K212325 | EEG-acpGYB · Traditional | Somnomedics GmbH | 06/15/2022SE |
| K212326 | AC Cream - Conductive pasteGYB · Traditional | Spes Medica Srl | 12/01/2021SE |
| K212787 | GT5 conductive & abrasive gelGYB · Traditional | Wuhan Greentek Pty , Ltd. | 11/08/2021SE |
| 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 |
More from Spes Medica Srl
| 510(k) | Device | Decision |
|---|---|---|
| K230711 | Pain Therapy Device(Model: P.T.S-X)NGX · Traditional | 05/16/2024SE |
| K231789 | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)NGX · Traditional | 03/11/2024SE |
| K231167 | Conductive Silicone Rubber ElectrodeGXY · Traditional | 08/09/2023SE |
| K231164 | Conductive carbon film electrodeGXY · Traditional | 08/09/2023SE |
| K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)NUH · Traditional | 11/12/2021SE |
| K212948 | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)NGX · Traditional | 11/01/2021SE |
| K202636 | Metallic Fabric ElectrodesGXY · Traditional | 08/16/2021SE |
| K202638 | Pain Therapy DeviceNGX · Traditional | 07/15/2021SE |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)GXY · Traditional | 05/13/2020SE |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…GXY · Traditional | 04/19/2018SE |
Questions and answers
When was DR-HO'S Electro Therapy Conductive Gel cleared by the FDA?
DR-HO'S Electro Therapy Conductive Gel (K200402) received a 510(k) decision of Substantially Equivalent on November 25, 2020, 280 days after the submission was received.
What is the product code of K200402?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.