FDA.reportPublic FDA data

ROOVJOY

Primary DI
00840001700031
Brand
ROOVJOY
Company
Shenzhen roundwhale technology co. LTD.
Model
R-E1
Device description
The EMS stimulation program stimulates healthy muscles in order to improve and facilitate muscle performance.
Published
2018-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K180956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180956000Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS StimulatorShenzhen Roundwhale Technology Co. , Ltd.2018-06-07NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840001700038PackageGS150In Commercial Distribution
00840001700031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084000170003810840001700038
00840001700031008400017000318400017000310840001700031

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation probeA non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device.

Regulatory Flags#

DUNS number
544587118
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971763600506ROOVJOYR-C101B2024-07-31
06971763600674ROOVJOYR-C101W2024-07-31
06971763600995ROOVJOYself-adhesive electrode2025-02-18
06971763600605ROOVJOYM100A2025-01-16
16971763600428ROOVJOYM100A2025-01-16
06971763600131ROOVJOYself-adhesive electrode2024-11-08
06971763600957ROOVJOYNeurological Therapy Devices Accessories2024-11-18
16971763600381ROOVJOYNeurological Therapy Devices Accessories2024-11-18
06971763600964ROOVJOYNeurological Therapy Devices Accessories2024-11-18
06971763600155ROOVJOYNeurological Therapy Devices Accessories2024-11-08
06971763600162ROOVJOYNeurological Therapy Devices Accessories2024-11-08
06971763600179ROOVJOYNeurological Therapy Devices Accessories2024-11-08
16971763600305ROOVJOYNeurological Therapy Devices Accessories2024-11-08
16971763600312ROOVJOYNeurological Therapy Devices Accessories2024-11-08
16971763600374ROOVJOYNeurological Therapy Devices Accessories2024-11-08
06971763600094ROOVJOYNeurological Therapy Devices Accessories2024-11-07
06971763600100ROOVJOYNeurological Therapy Devices Accessories2024-11-07
06971763600117ROOVJOYself-adhesive electrode2024-11-07
06971763600087ROOVJOYNeurological Therapy Devices Accessories2024-11-07
16971763600350ROOVJOYNeurological Therapy Devices Accessories2024-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00850051584048Neuro20 PRO SystemNEURO20 TECHNOLOGIES CORP.NGX2026-05-05
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
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
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
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