FDA.reportPublic FDA data

RENPHO

Primary DI
00810140062697
Brand
RENPHO
Company
Joicom Corporation
Model
SM9116
Device description
Wireless TENS & EMS
Published
2025-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810140062694PackageGS136In Commercial Distribution
00810140062697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081014006269410810140062694
00810140062697008101400626978101400626970810140062697

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.

Regulatory Flags#

DUNS number
033774836
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810140063045RENPHO Eye MassagerR-WME062026-05-26
00810140063014RENPHOPUS-R-WMV01-2-BK2026-05-08
00810140063021RENPHOPUS-R-WMG18-BK2026-05-08
00810140063038RENPHOPUS-R-WMG09-GY2026-05-08
00810140063007RENPHOPUS-R-MSC05-BK2026-04-20
00810140062994RENPHOPUS-R-MSC06-BK2026-04-08
00810140062895RENPHOPUS-R-WMF01-WH2026-01-04
00810140062901RENPHOPUS-R-A018-BU-B12026-01-04
10810140062892RENPHOPUS-R-WMF01-WH2026-01-04
10810140062908RENPHOPUS-R-A018-BU-B12026-01-04
00810140062864RENPHOPUS-R-WMF08-BU2025-12-16
10810140062861RENPHOPUS-R-WMF08-BU2025-12-16
00810140062857RENPHOR-WMG242025-12-03
10810140062854RENPHOR-WMG242025-12-03
00810140062840RENPHOR-MSB042025-11-25
10810140062847RENPHOR-MSB042025-11-25
00810140062123RENPHOR-WMG102024-10-16
00810140062826RENPHOPUS-R-WMF09-BK2025-11-05
00810140062819RENPHOES-CS20M2025-10-24
00810140062802RENPHO Massage GunR-WMG152025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2025-03-31
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-03-31
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
16977159460065versatone-xtGymmax Technology (Shenzhen) Co., Ltd.NGX2024-12-19
16977159460072versatoneGymmax Technology (Shenzhen) Co., Ltd.NGX2024-12-19
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00023601272027TENS 7000Drive Devilbiss HealthcareNGX2024-11-22
00023601272027TENS 7000Drive Devilbiss HealthcareNUH2024-11-22
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20
00023601680068TENS 7000Drive Devilbiss HealthcareNGX2024-10-29
00023601680068TENS 7000Drive Devilbiss HealthcareNUH2024-10-29
00023601680372TENS 7000Drive Devilbiss HealthcareNUH2024-10-29
00023601680372TENS 7000Drive Devilbiss HealthcareNGX2024-10-29
08809851470053eMVFitWEERO Co., Ltd.IPF2024-10-22
08032625822851GLOBUSDOMINO SRLIPF2024-10-17
08032625828037GLOBUSDOMINO SRLIPF2024-10-17
08032625829799GLOBUSDOMINO SRLIPF2024-10-17
08032625829805GLOBUSDOMINO SRLIPF2024-10-17
08032625829812GLOBUSDOMINO SRLIPF2024-10-17
B108899PO11C1ENUS0150EMSCULPT NEOBTL INDUSTRIES LIMITEDIPF2024-09-23
00023601251008AccuReliefDrive Devilbiss HealthcareNUH2024-09-09