510(k) K161154
K161154 is an FDA 510(k) premarket notification submitted by Spr Therapeutics, LLC for the device "Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs". The FDA issued a decision of Substantially Equivalent on July 23, 2016. The device falls under product code NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Spr Therapeutics, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2016
- Date Received
- April 25, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
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,