Easy@Home Electronic Pulse Stimulator

GUDID 10810038633944

EASY HEALTHCARE CORPORATION

Hand-held electric massager
Primary Device ID10810038633944
NIH Device Record Key4de2d095-5c19-41f3-91dd-c7fe5da59dfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Electronic Pulse Stimulator
Version Model NumberEHE015BLE
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 Batchtrue
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
GS100810038633947 [Primary]
GS110810038633944 [Package]
Contains: 00810038633947
Package: [80 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-08
Device Publish Date2022-08-31

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