FDA.reportPublic FDA data

HiDow

Primary DI
00851640007849
Brand
HiDow
Company
Hi-Dow International Incorporated
Model
HD-09H
Device description
Neck Wrap
Published
2022-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210383000Wrap Accessory ElectrodesHi-Dow International, Inc.2021-11-12GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851640007849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851640007849008516400078498516400078490851640007849

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, reusableAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124034476
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810093080786PainPod HD-5N-23A2025-12-09
00810093080793PainPod HD-5N-23A2025-12-09
00810093080014PainPodJQ-5C-07A2022-05-16
00851640007573COPPER Fit JQ-5C-07A2020-06-24
00851640007511PainPodJQ-5C-M2020-06-15
00851640007498HiDowJQ-5C-07A 2019-11-21
00851640007504SomacareJQ-5C-C2016-11-02
09351609000023PainPodJQ-5C-B2018-11-02
00851640007009HiDowJQ-5C-E2016-09-01
00851640007016Hi-DowJQ-5C-E2016-09-01
00851640007023HiDowJQ-5C-C2016-09-01
00851640007030HiDowJQ-5C-C2016-09-01
00851640007047HiDowJQ-5C-S2016-09-01
00851640007054HiDowJQ-5C-S2016-09-01
00851640007061HiDowJQ-5C-S2016-09-01
00851640007078HiDowJQ-5C-S2016-09-01
00851640007085HiDowJQ-5C-R2016-09-01
00851640007092HiDowJQ-5C-R2016-09-01
00851640007108HiDowJQ-5C-R2016-09-01
00851640007115HiDowJQ-5C-R2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08