TheraKnit

GUDID B1870070

Conductive duo-elbow, dual polarity, 1/package

NEUROTRON MEDICAL, INC.

Transcutaneous electrical stimulation electrode
Primary Device IDB1870070
NIH Device Record Keycbe88bf8-45f9-48b5-bdc0-673e90b8b7e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraKnit
Version Model NumberTKG-3022
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
HIBCCB1870070 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-08

On-Brand Devices [TheraKnit]

B1870670Conductive pad kit: 2 pc. 3 in. x 4.5 in.; 1 pc. 3 in. x 7 in.; 1 pc. 1.5 in. x 7 in.
B1870141Conductive pad, 1.5 in. x 8 in., 2/package
B1870121Conductive pad, 3 in. x 5 in., 2/package
B1870111Conductive pad, 2 in. x 3 in., 2/package
B1870090Conductive duo-glove, dual polarity, 1/package
B1870070Conductive duo-elbow, dual polarity, 1/package
B1870060Conductive sock, dual polarity, 1/package
B1870050Conductive knee, single polarity, 1/package
B1870020Conductive sock, single polarity, 1/package
B1870010Conductive glove, single polarity, 1/package
B1870080Conductive duo-knee, dual polarity, 1/package

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