FDA.reportPublic FDA data

HiDow

Primary DI
00810093080373
Brand
HiDow
Company
Hi-Dow International Incorporated
Model
HD-19A-RECEIVER
Device description
Universal Receiver
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233461000Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)Hi-Dow International, Inc.2024-01-19NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810093080373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810093080373008100930803738100930803730810093080373

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124034476
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810093080854PainPodJQ-5C-C2026-10-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971763600889ROOVJOYShenzhen roundwhale technology co. LTD.NGX2026-11-05
06971763600889ROOVJOYShenzhen roundwhale technology co. LTD.NUH2026-11-05
00860015112491Therapist’s Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-11-01
08682250582028Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582035Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582042Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582059Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
10816312029427Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-10-27
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023112SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023129SENSADERM BLUEVision Quest Industries IncorporatedGXY2026-10-23
00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
00810093080854PainPodHi-Dow International IncorporatedNGX2026-10-19
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13