PressOn Electrode Headset
FDA 510(k) K190801 · Rhythmlink International, LLC
510(k) numberK190801
Submission
- Device name
- PressOn Electrode Headset
- Applicant
- Rhythmlink International, LLC
Columbia, SC, US - Received
- March 29, 2019
- Decision date
- July 10, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241045 | Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional | Technomed Europe | 12/11/2024SE |
| K232581 | Medical Disposable Sterile Needle ElectrodeGXZ · Traditional | Suzhou Haishen Medical Device Associates Co., Ltd. | 12/04/2023SE |
| K231691 | Phantom XL Insulated DilatorsGXZ · Special | TeDan Surgical Innovations, Inc. | 06/29/2023SE |
| K200984 | Guardian Needle ElectrodeGXZ · Special | Rhythmlink International, LLC | 05/27/2020SE |
| K192603 | Spes Medica Subdermal Needle ElectrodesGXZ · Traditional | Spes Medica Srl | 11/22/2019SE |
| K161566 | DMS Disposable Subdermal Needle ElectrodesGXZ · Traditional | Daehan Medical Systems Co., Ltd. | 12/21/2016SE |
| K142470 | E-Shield Multi-paried Subdermal Needle ElectrodesGXZ · Special | Neuroinvent, Inc. | 11/05/2014SE |
| K140200 | E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional | Neuroinvent, Inc. | 07/18/2014SE |
| K130220 | MR Conditional Presson ElectrodeGXZ · Traditional | Rhythmlink International, LLC | 07/22/2013SE |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional | Technomed Europe | 07/19/2013SE |
More from Technomed Europe
| 510(k) | Device | Decision |
|---|---|---|
| K203079 | MR Conditional Sticky Pad ElectrodeGXY · Traditional | 02/09/2021SE |
| K200984 | Guardian Needle ElectrodeGXZ · Special | 05/27/2020SE |
| K191225 | EEG Electrode TemplateGXY · Traditional | 08/05/2019SE |
| K172503 | MR Conditional Cup Electrode, MR Conditional Webb ElectrodeGXY · Traditional | 12/01/2017SE |
| K132138 | Rhythmlink Disposable Concentric Stimulating ProbePDQ · Traditional | 04/11/2014SE |
| K130220 | MR Conditional Presson ElectrodeGXZ · Traditional | 07/22/2013SE |
| K130287 | MR Conditional Cup Electrode, MR Conditional Webb ElectrodeGXY · Traditional | 05/30/2013SE |
| K121347 | Presson ElectrodeGXZ · Traditional | 07/12/2012SE |
| K120342 | Emg Recording Electrode AssemblyIKT · Traditional | 06/22/2012SE |
| K112435 | Rhythmlink Monopolar Stimulating InstrumentETN · Special | 09/22/2011SE |
Questions and answers
When was PressOn Electrode Headset cleared by the FDA?
PressOn Electrode Headset (K190801) received a 510(k) decision of Substantially Equivalent on July 10, 2019, 103 days after the submission was received.
What is the product code of K190801?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.