HiDow, TrueStim

GUDID 00851640007160

Wireless Receiver

Hi-Dow International Incorporated

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00851640007160
NIH Device Record Key3c88d8f6-df40-4e84-8387-0182e109bafe
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiDow, TrueStim
Version Model NumberJQ-5C-N-RECEIVER
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
GS100851640007160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

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 Date2017-01-09

Devices Manufactured by Hi-Dow International Incorporated

00810093080373 - HiDow2024-10-30 Universal Receiver
00810093080205 - MYOPUX2024-07-11 MYOPUX Xpansion Pux Black
00810093080045 - HiDow2024-05-17 Pro-Touch Wireless 6-12 Black & White
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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