Hidow SuperTens

GUDID 00851640007269

Mini Electronic Muscle Stimulator with Electrode

Hi-Dow International Incorporated

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00851640007269
NIH Device Record Key80f20ae7-1e51-43cb-b59b-e1bd0d6a4c92
Commercial Distribution StatusIn Commercial Distribution
Brand NameHidow SuperTens
Version Model NumberJQ-5C-W
Company DUNS124034476
Company NameHi-Dow International Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851640007269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-28
Device Publish Date2017-02-22

Devices Manufactured by Hi-Dow International Incorporated

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00810093080137 - MYOPUX2024-05-17 MYOPUX eDN White
00810093080144 - MYOPUX2024-05-17 MYOPUX eDN Xpansion White&Black
00081009308007 - TrueStim2023-10-06 Pulsed Electromagnetic Field Wrap, Black, lower limb wrap
00810093080014 - PainPod2022-05-24 TENS for pain relief
00851640007672 - HiDow2022-05-24 Wrap Accessory Electrode, AcuElbow Wrap

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