Easy@Home Heat TENS unit with Replacement Pads

GUDID 10810038631544

EASY HEALTHCARE CORPORATION

Electric pad localized-body heating system
Primary Device ID10810038631544
NIH Device Record Keyd63ae50b-a010-4153-940f-cd692dcb6abf
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Heat TENS unit with Replacement Pads
Version Model NumberETP018
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count2
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
GS100810038631547 [Primary]
GS110810038631544 [Package]
Contains: 00810038631547
Package: [400 Units]
In Commercial Distribution
GS190855944007669 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRTPad, Heating, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-12
Device Publish Date2021-07-02

On-Brand Devices [Easy@Home Heat TENS unit with Replacement Pads]

10855944007663ETP018
10810038631544ETP018

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