HiDow

GUDID 00851640007351

HiDow XPDS 18

Hi-Dow International Incorporated

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00851640007351
NIH Device Record Key92519a04-2b09-4b9f-b2c5-849ce2819930
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiDow
Version Model NumberJQ-5C-R
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
GS100851640007351 [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 Date2017-06-14

On-Brand Devices [HiDow]

00851640007436PRO TOUCH WIRELESS 6-12
00851640007368HiDow XPDS 18
00851640007351HiDow XPDS 18
00851640007344HiDow XPDS 24 COPPER
00851640007337HiDow XPDS 24 BLACK
00851640007313HiDow XPD 12 Black
00851640007306HiDow XPD 12, Silver
00851640007245Wireless Reciver 6-12
00851640007177Pro Touch Wireless System 6-12
00851640007153Wireless TENS/EMS-49
00851640007146Wireless TENS/EMS System-24
00851640007115AcuXPD-S BLUE
00851640007108AcuXPD-S PINK
00851640007092AcuXPD-S BLACK
00851640007085AcuXPD-S Silver
00851640007078AcuXPD-Blue
00851640007061AcuXPD-Pink
00851640007054AcuXPD-Black
00851640007047AcuXPD-Silver
00851640007030AcuXP Micro-Black
00851640007023AcuXP Micro Silver
00851640007009AcuXP iSmart - White
00851640007610AcuGlove Wrap Accessories Electrode
00851640007498HiDow Spot,Electronic Muscle Stimulator
00851640007580Wireless TENS+EMS
00851640007627AcuSocks Wrap Accessories Electrode
00851640007856Shoulder Wrap
00851640007849Neck Wrap
00851640007689AcuWrist Wrap
00851640007665AcuKnee Wrap
00851640007603Wrap Accessory Electrodes for feet Black
00851640007870Wrap Accessory Electrode, Foot Wrap
00851640007863Wraps Accessory Electrodes, pro-belt
00851640007672Wrap Accessory Electrode, AcuElbow Wrap
00810093080045Pro-Touch Wireless 6-12 Black & White
00810093080373Universal Receiver

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