FDA.reportPublic FDA data

ROOVJOY

Primary DI
10840001700007
Brand
ROOVJOY
Company
Shenzhen roundwhale technology co. LTD.
Model
M100B
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
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840001700007PackageGS150In Commercial Distribution
00840001700000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084000170000710840001700007
00840001700000008400017000008400017000000840001700000

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 LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
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
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11