FDA.reportPublic FDA data

vniolife

Primary DI
06974241370533
Brand
vniolife
Company
Guangzhou Hua Kai Electronic Technology Co., Ltd.
Model
HK701C
Device description
Ems Foot Stimulator
Published
2023-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221251000Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.2022-07-29NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974241370533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974241370533069742413705336974241370533

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528170971
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974241370366veicomtechHK7012023-01-17
06974241370441vniolifeHK7012023-01-17
06974241370458lecuagHK7012023-01-17
06974241370465veicomtechHK701A2023-01-17
06974241370472vniolifeHK701A2023-01-17
06974241370489lecuagHK701A2023-01-17
06974241370496veicomtechHK701B2023-01-17
06974241370502vniolifeHK701B2023-01-17
06974241370519lecuagHK701B2023-01-17
06974241370526veicomtechHK701C2023-01-17
06974241370540lecuagHK701C2023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNUH2026-09-03
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
00622356753760Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356753937Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
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00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
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00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
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088095244977693H Heating Belt3H, Co., LtdIRT2026-07-29
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088095244977833H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-29
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
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06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00671152103873Bug Bite Relief PenJc & A Canada Inc.IRT2026-07-16
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00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16