Procare Tens Machine

GUDID 00372217037019

ARISE MEDICAL LLC

Transcutaneous electrical stimulation lead
Primary Device ID00372217037019
NIH Device Record Key30a0d59f-0e9d-44ec-9e3f-4a51d804718e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcare Tens Machine
Version Model Number240498
Company DUNS081149273
Company NameARISE MEDICAL LLC
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
GS100372217037019 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-06-27

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