FDA.reportPublic FDA data

Muscle Stimulator

Primary DI
00199874125305
Brand
Muscle Stimulator
Company
Shenzhen Yiran Intelligence Co., Ltd.
Model
RX10-PRO
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231648000Muscle StimulatorShenzhen Yiran Intelligent Co., Ltd.2024-03-01NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199874125305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199874125305001998741253051998741253050199874125305

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
707408239
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199874173993Muscle StimulatorU132026-01-22
00198715239751HomedicsTENS-160J2025-01-20
00198715084832Muscle stimulatorYR-U8-PRO2024-09-13
00198715187830Muscle StimulatorYR-U80-PRO-MAX2024-09-13
00198715286663Muscle StimulatorYR-U80-PRO2024-09-13
00198715837629Muscle StimulatorYR-U82024-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988435AUVONUAN HEALTHCARE LIMITEDNGX2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNGX2026-05-06
00850051584048Neuro20 PRO SystemNEURO20 TECHNOLOGIES CORP.NGX2026-05-05
00850080988381AUVONUAN HEALTHCARE LIMITEDNGX2026-04-29
00850080988398AUVONUAN HEALTHCARE LIMITEDNGX2026-04-29
00850080988404AUVONUAN HEALTHCARE LIMITEDNGX2026-04-29
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00850080988145AUVONUAN HEALTHCARE LIMITEDNGX2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNGX2026-03-19
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNGX2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNGX2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNGX2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00850073128138AVCOOADP HEALTH LIMITEDNGX2025-08-25
00850073128121AVCOOADP HEALTH LIMITEDNGX2025-08-25
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00850073128107AVCOOADP HEALTH LIMITEDNGX2025-07-02
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128091AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128084AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128046AVCOOADP HEALTH LIMITEDNGX2025-04-03