FDA 510(k) Applications for Medical Device Product Code: NHI (Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief)

FDA 510(k) Applications for Medical Device Product Code "NHI"
(Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K061166	BIOWAVE CORPORATION	DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM	08/15/2006
K220397	DyAnsys, Inc.	ANSiStim-PP	05/12/2022
K212859	DyAnsys, Inc.	First Relief	12/20/2021
K213188	DyAnsys, Inc.	Primary Relief	01/31/2022
K221425	DyAnsys, Inc.	Primary Relief	09/13/2022
K223306	SPR Therapeutics, Inc.	SPRINT Peripheral Nerve Stimulation (PNS) System	01/25/2023
K181422	SPR Therapeutics, Inc.	SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit	07/31/2018
K202660	SPR Therapeutics, Inc.	SPRINT PNS System	01/22/2021
K211801	SPR Therapeutics, Inc.	SPRINT PNS System	10/13/2021
K161154	SPR THERAPEUTICS, LLC	Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs	07/23/2016
K170902	SPR Therapeutics, LLC	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	06/26/2017
K022241	VERTIS NEUROSCIENCE, INC.	VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX	09/11/2002
K011702	VERTIS NEUROSCIENCE, INC.	VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX	12/21/2001