Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
FDA 510(k) K170902 · Spr Therapeutics, LLC
Submission
- Device name
- Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
- Applicant
- Spr Therapeutics, LLC
Cleveland, OH, US - Received
- March 28, 2017
- Decision date
- June 26, 2017
- 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 |
| K221425 | Primary ReliefNHI · Traditional | Dyansys, Inc. | 09/13/2022SE |
| 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 |
| 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 |
|---|---|---|
| K240974 | SPRINT PNS SystemSCN · Traditional | 04/14/2026SE |
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) SystemNHI · Traditional | 01/25/2023SE |
| K211801 | SPRINT PNS SystemNHI · Traditional | 10/13/2021SE |
| K202660 | SPRINT PNS SystemNHI · Traditional | 01/22/2021SE |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…NHI · Traditional | 07/31/2018SE |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…NHI · Traditional | 07/23/2016SE |
Questions and answers
When was Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit cleared by the FDA?
Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit (K170902) received a 510(k) decision of Substantially Equivalent on June 26, 2017, 90 days after the submission was received.
What is the product code of K170902?
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.