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510(k) K161154

Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs by Spr Therapeutics, LLC — Product Code NHI

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,

Other clearances by Spr Therapeutics, LLC

  • K223306 — SPRINT Peripheral Nerve Stimulation (PNS) System (January 25, 2023)
  • K211801 — SPRINT PNS System (October 13, 2021)
  • K202660 — SPRINT PNS System (January 22, 2021)
  • K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Sti (July 31, 2018)
  • K170902 — Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure (June 26, 2017)

Other clearances for product code NHI

  • K223306 — SPRINT Peripheral Nerve Stimulation (PNS) System (January 25, 2023)
  • K221425 — Primary Relief (September 13, 2022)
  • K220397 — ANSiStim-PP (May 12, 2022)
  • K213188 — Primary Relief (January 31, 2022)
  • K212859 — First Relief (December 20, 2021)
  • K211801 — SPRINT PNS System (October 13, 2021)
  • K202660 — SPRINT PNS System (January 22, 2021)
  • K181422 — SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Sti (July 31, 2018)
  • K170902 — Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure (June 26, 2017)
  • K061166 — DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM (August 15, 2006)