PDC Restorer

GUDID B1870770

Conductive duo-knee, dual polarity, 1/package

NEUROTRON MEDICAL, INC.

Transcutaneous electrical stimulation electrode, single-use
Primary Device IDB1870770
NIH Device Record Key29686d81-c718-42a2-8ed4-7196a817c381
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDC Restorer
Version Model NumberPLB066-3024C
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 Batchtrue
Serial Numberfalse
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
HIBCCB1870770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

On-Brand Devices [PDC Restorer]

B1870620Electrolyte solution, 4 oz. spray bottle
B1870490Conductive duo-glove, dual polarity, 1/package
B1870480Conductive duo-sock, dual polarity, 1/package
B1870460Conductive sock (std.), single polarity, 1/package
B1870450Conductive glove, single polarity, 1/package
B1870740Conductive duo-elbow, dual polarity, 1/package
B1870760Conductive duo-sock, dual polarity, X-Large, 1/package
B1870770Conductive duo-knee, dual polarity, 1/package
B1870780Conductive pad, 3 in. x 5 in., 2/package
B1870790Conductive pad, 2 in. x 3 in., 2/package
B1870470Conductive pad, 1.5 in. x 8 in., 2/package

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