Tech Dots - Adhesive and conductive gel
FDA 510(k) K190050 · Spes Medica Srl
510(k) numberK190050
Submission
- Device name
- Tech Dots - Adhesive and conductive gel
- Applicant
- Spes Medica Srl
Battipaglia (Sa), IT - Received
- January 10, 2019
- Decision date
- July 19, 2019
- 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 |
| 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 |
More from Spes Medica Srl
| 510(k) | Device | Decision |
|---|---|---|
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip…GYC · Traditional | 11/10/2022SE |
| K212326 | AC Cream - Conductive pasteGYB · Traditional | 12/01/2021SE |
| K192606 | SAC2 - Electrode CreamGYB · Traditional | 01/17/2020SE |
| K192603 | Spes Medica Subdermal Needle ElectrodesGXZ · Traditional | 11/22/2019SE |
| K133348 | Stim ProbeETN · Traditional | 11/21/2014SE |
| K120494 | Disposable Adhesive Surface ElectrodeGXY · Traditional | 06/11/2012SE |
| K093373 | Laryngeal Surface ElectrodeETN · Traditional | 08/24/2010SE |
| K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,IKT · Traditional | 08/11/2009SE |
Questions and answers
When was Tech Dots - Adhesive and conductive gel cleared by the FDA?
Tech Dots - Adhesive and conductive gel (K190050) received a 510(k) decision of Substantially Equivalent on July 19, 2019, 190 days after the submission was received.
What is the product code of K190050?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.