MultiStim ECO
FDA 510(k) K162086 · PAJUNK GmbH Medizintechnologie
510(k) numberK162086
Submission
- Device name
- MultiStim ECO
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- July 27, 2016
- Decision date
- January 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BXN – Stimulator, Nerve, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
Other 510(k)s with product code BXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 10/16/2022SE |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special | Easy Med Instrument Co., Ltd. | 05/13/2016SE |
| K143095 | MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional | Halyard Health, Inc. | 03/24/2015SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 11/06/2014SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | Sunmed, LLC | 03/28/2013SE |
| K111985 | Myoguide System Model 8008BXN · Traditional | Intronix Technologies Corp. | 12/30/2011SE |
| K110118 | Stimtrode Single Use Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 02/17/2011SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/03/2009SE |
| K091155 | AscendBXN · Traditional | Neurometrix, Inc. | 09/03/2009SE |
More from Neurometrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243690 | SonoMSKBSP · Traditional | 07/01/2025SE |
| K243682 | SonoPlex STIM; SonoPlex IIBSP · Traditional | 06/27/2025SE |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional | 06/25/2025SE |
| K243525 | SonoTAP and SonoTAP IIBSP · Traditional | 03/24/2025SE |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional | 11/22/2024SE |
| K241954 | SonoBlock; SonoBlock IIBSP · Traditional | 09/11/2024SE |
| K230701 | Stim2GoIPF · Traditional | 11/24/2023SE |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0HAW · Special | 02/22/2023SE |
| K220897 | Disposable Brain Biopsy Needle 2.0HAW · Traditional | 08/17/2022SE |
| K202699 | E-Cath STIM acc. TsuiCAZ · Special | 12/29/2020SE |
Questions and answers
When was MultiStim ECO cleared by the FDA?
MultiStim ECO (K162086) received a 510(k) decision of Substantially Equivalent on January 6, 2017, 163 days after the submission was received.
What is the product code of K162086?
The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.