FDA.reportPublic FDA data

510(k) K201431

Device
OGYILI TENS/NMES Stimulator
Applicant
Gongguan Tutamen Metalwork Co., Ltd.
510(k) number
K201431
Product code
GZJ
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-09
Date received
2020-06-01
Regulation
882.5890
Classification name
Stimulator, Nerve, Transcutaneous, 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
Charles Shen
Address
#2, Huanggoutang Rd., Shahu, Tangxia Town Dongguan CN 523001 523001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GZJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252767actiTENS miniSublimed2026-01-16
K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC2025-08-15
K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.2024-08-30
K241228TENSWaveZynex Medical Officer2024-08-27
K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited2024-04-19
K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)Wuxi Jiajian Medical Instrument Co., Ltd.2023-01-24
K212618iRelieve Microcurrent Pain Relief SystemFast Track Technologies, Inc.2022-09-14
K213802StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd.2022-08-26
K220578Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)Bozhou Rongjian Medical Appliance Co., Ltd.2022-05-25
K220503TENS device-EmeTerm 2, Model: YF-ZTY-E2Wat Medical Technology, Inc.2022-04-23
K202893Transcutaneous Electrical Nerve StimulatorWuxi Jiajian Medical Instrument Co., Ltd.2021-06-18
K202186TrueRelief DeviceTruerelief2021-03-23
K210202BioWaveGO RXBiowave Corporation2021-02-24
K201458Scrambler Therapy Technology (Model ST-5A)Delta International Services & Logistics S.R.L2020-12-23
K202159actiTENSSublimed2020-12-22