FDA.reportPublic FDA data

ROOVJOY

Primary DI
06971763600605
Brand
ROOVJOY
Company
Shenzhen roundwhale technology co. LTD.
Model
M100A
Published
2025-01-16
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
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971763600428PackageGS150In Commercial Distribution
06971763600605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697176360042816971763600428
06971763600605069717636006056971763600605

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
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
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
16971763600367ROOVJOYNeurological Therapy Devices Accessories2024-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-29
08032625829843NerveOTXDOMINO SRLIPF2026-07-28
08032625829843NerveOTXDOMINO SRLGZJ2026-07-28
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.GZJ2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03