Primary Relief
FDA 510(k) K221425 · Dyansys, Inc.
510(k) numberK221425
Submission
- Device name
- Primary Relief
- Applicant
- Dyansys, Inc.
San Mateo, CA, US - Received
- May 16, 2022
- Decision date
- September 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHI – Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5890
- Specialty
- Neurology
Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,
Other 510(k)s with product code NHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) SystemNHI · Traditional | Spr Therapeutics, Inc. | 01/25/2023SE |
| K220397 | ANSiStim-PPNHI · Traditional | Dyansys, Inc. | 05/12/2022SE |
| K213188 | Primary ReliefNHI · Traditional | Dyansys, Inc. | 01/31/2022SE |
| K212859 | First ReliefNHI · Traditional | Dyansys, Inc. | 12/20/2021SE |
| K211801 | SPRINT PNS SystemNHI · Traditional | Spr Therapeutics, Inc. | 10/13/2021SE |
| K202660 | SPRINT PNS SystemNHI · Traditional | Spr Therapeutics, Inc. | 01/22/2021SE |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…NHI · Traditional | Spr Therapeutics, Inc. | 07/31/2018SE |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…NHI · Traditional | Spr Therapeutics, LLC | 06/26/2017SE |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…NHI · Traditional | Spr Therapeutics, LLC | 07/23/2016SE |
| K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy SystemNHI · Traditional | Biowave Corporation | 08/15/2006SE |
More from Biowave Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K221231 | Drug Relief v1PZR · Special | 06/06/2022SE |
| K220397 | ANSiStim-PPNHI · Traditional | 05/12/2022SE |
| K213188 | Primary ReliefNHI · Traditional | 01/31/2022SE |
| K212859 | First ReliefNHI · Traditional | 12/20/2021SE |
| K211971 | Drug Relief v1PZR · Traditional | 11/05/2021SE |
| K202940 | First Relief v1QHH · Traditional | 12/29/2020SE |
| K173861 | Drug ReliefPZR · Traditional | 05/02/2018SE |
| K170391 | ANSiStim-PPBWK · Special | 03/09/2017SE |
| K141168 | AnsistimBWK · Traditional | 05/15/2015SE |
| K091397 | Ecscope 200DPS · Traditional | 07/08/2009SE |
Questions and answers
When was Primary Relief cleared by the FDA?
Primary Relief (K221425) received a 510(k) decision of Substantially Equivalent on September 13, 2022, 120 days after the submission was received.
What is the product code of K221425?
The FDA product code is NHI – Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.