TENS MAKER

GUDID 04719880810123

HIVOX BIOTEK INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID04719880810123
NIH Device Record Key3c9fd98b-94fd-4435-96df-66ae42f9f781
Commercial Distribution StatusIn Commercial Distribution
Brand NameTENS MAKER
Version Model NumberWE-201
Company DUNS658030473
Company NameHIVOX BIOTEK INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104719880810123 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-30
Device Publish Date2022-03-22

On-Brand Devices [TENS MAKER]

04719880810000WT-110
04719880810154WT-110-2
04719880810147WT-110-RF4
04719880810123WE-201

Trademark Results [TENS MAKER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TENS MAKER
TENS MAKER
88787538 not registered Live/Pending
HIVOX BIOTEK INC.
2020-02-06

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