Easy@Home Mini Electronic Pulse Stimulator

GUDID 00850253007147

EASY HEALTHCARE CORPORATION

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Primary Device ID00850253007147
NIH Device Record Key79173b07-f024-4a4e-99f5-45a89eaef817
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Mini Electronic Pulse Stimulator
Version Model NumberEHE029G
Company DUNS080278407
Company NameEASY HEALTHCARE 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 Numbertrue
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
GS100850253007147 [Primary]
GS110850253007144 [Package]
Package: [20 Units]
In Commercial Distribution

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 Number4
Public Version Date2018-11-26
Device Publish Date2016-08-05

On-Brand Devices [Easy@Home Mini Electronic Pulse Stimulator]

00850253007147EHE029G
10855944007908EHE029N
10810038630257EHE029N
10810038630165EHE029G

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