Etekcity TENS Unit

GUDID 00817915020012

ETEKCITY CORPORATION

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID00817915020012
NIH Device Record Key0872ae02-dd3c-4fd6-8b96-baf5e6a2a012
Commercial Distribution StatusIn Commercial Distribution
Brand NameEtekcity TENS Unit
Version Model NumberETU-134
Company DUNS079578783
Company NameETEKCITY CORPORATION
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817915020012 [Primary]
GS110817915020019 [Package]
Package: Master Case [40 Units]
In Commercial Distribution

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 Number4
Public Version Date2019-10-23
Device Publish Date2019-04-22

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10817915028213 - Etekcity Smart Fitness Scale2021-09-01

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