FDA.reportPublic FDA data

iSTIM

Primary DI
04719871185841
Brand
iSTIM
Company
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Model
iSTIM X1
Device description
HEATING TENS/EMS
Published
2024-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871185841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871185841047198711858414719871185841

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657383535
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871189108iSTIMiSTIM PR-13A2023-08-30
04719871184950iSTIMiSTIM PR-02-22023-08-25
04719871185049iSTIMiSTIM PR-03A2023-08-25
04719871189092iSTIMiSTIM PR-02A2023-08-25
04719871185605iSTIMA12025-12-03
04719871186015Pain ManagementHC-890A2025-12-03
04719871186039EverywayZ42025-12-03
04719871189276EverywaySG50D2023-08-30
04719871189283EverywaySG43682023-08-30
04719871189290EverywaySG601472023-08-30
04719871189306EverywaySG40402023-08-30
04719871189313EverywaySG75D2023-08-30
04719871189269EverywaySG57952023-08-25
04719871183656EverywaySG70902022-03-17
04719871184202EverywaySG50502022-03-17
04719871184219EverywaySG501002022-03-17
04719871184325EverywayS551052022-03-17
04719871184332EverywayS801202022-03-17
04719871185346EverywaySG50752022-03-17
04719871185131iSTIMiSTIM EV-9062023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
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00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
09413000135374Flowpresso Compression DeviceMEDELLA HEALTH LIMITEDIRT2025-10-16
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2025-03-31
00031262116291HomedicsHuizhou XINYI Technology Co., LTDIRT2025-02-01