FDA.reportPublic FDA data

510(k) K212859

Device
First Relief
Applicant
Dyansys, Inc.
510(k) number
K212859
Product code
NHI
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-20
Date received
2021-09-08
Regulation
882.5890
Classification name
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Srini Nageshwar
Address
300, N. Bayshore Blvd. San Mateo CA US 94401 94401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.2023-01-25
K221425Primary ReliefDyansys, Inc.2022-09-13
K220397ANSiStim-PPDyansys, Inc.2022-05-12
K213188Primary ReliefDyansys, Inc.2022-01-31
K211801SPRINT PNS SystemSpr Therapeutics, Inc.2021-10-13
K202660SPRINT PNS SystemSpr Therapeutics, Inc.2021-01-22
K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer KitSpr Therapeutics, Inc.2018-07-31
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, LLC2017-06-26
K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 PacksSpr Therapeutics, LLC2016-07-23
K061166DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEMBiowave Corporation2006-08-15
K022241VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXXVertis Neuroscience, Inc.2002-09-11
K011702VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXXVertis Neuroscience, Inc.2001-12-21