FDA.reportPublic FDA data

ROOVJOY

Primary DI
10840001700182
Brand
ROOVJOY
Company
Shenzhen roundwhale technology co. LTD.
Model
MINI TENS
Device description
It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back, joint, hip,upper extremities (arm) and lower extremities (leg) due to 6 strain from exercise or normal household work activities.
Published
2022-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840001700182PackageGS150In Commercial Distribution
00840001700253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084000170018210840001700182
00840001700253008400017002538400017002530840001700253

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544587118
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
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
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128046AVCOOADP HEALTH LIMITEDNGX2025-04-03