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FDA 510(k)

SPRINT Peripheral Nerve Stimulation (PNS) System

K-Number: K223306 · 2023-01-25

ApplicantSpr Therapeutics, Inc.
Decision Date2023-01-25
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPRINT Peripheral Nerve Stimulation (PNS) System is a medical device manufactured by Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-25 under approval number K223306. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRINT Peripheral Nerve Stimulation (PNS) System?

SPRINT Peripheral Nerve Stimulation (PNS) System is a medical device that received FDA 510(k) clearance on 2023-01-25. It is manufactured by Spr Therapeutics, Inc.. The 510(k) number is K223306.

When was SPRINT Peripheral Nerve Stimulation (PNS) System approved by the FDA?

SPRINT Peripheral Nerve Stimulation (PNS) System received FDA 510(k) clearance on 2023-01-25, under approval number K223306.

What company makes SPRINT Peripheral Nerve Stimulation (PNS) System?

SPRINT Peripheral Nerve Stimulation (PNS) System is manufactured by Spr Therapeutics, Inc..

What is the FDA product code for SPRINT Peripheral Nerve Stimulation (PNS) System?

The FDA product code for SPRINT Peripheral Nerve Stimulation (PNS) System is NHI.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Spr Therapeutics, Inc.

K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit K211801SPRINT PNS System K202660SPRINT PNS System K240974SPRINT PNS System

Related Devices (Code: NHI)

K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 PacksSpr Therapeutics, LLC K170902Sprint 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 KitSpr Therapeutics, LLC K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer KitSpr Therapeutics, Inc. K212859First ReliefDyansys, Inc. K211801SPRINT PNS SystemSpr Therapeutics, Inc. K202660SPRINT PNS SystemSpr Therapeutics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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