Relief Combo

GUDID B1870240

TENS-EMS device

NEUROTRON MEDICAL, INC.

Transcutaneous electrical stimulation electrode
Primary Device IDB1870240
NIH Device Record Key33f72cea-6fe0-4c48-99bf-a70e142488f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelief Combo
Version Model NumberPLB043-5010
Company DUNS147018519
Company NameNEUROTRON MEDICAL, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1870240 [Primary]

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-12
Device Publish Date2016-09-23

Devices Manufactured by NEUROTRON MEDICAL, INC.

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