Search Results
Found 1 results
510(k) Data Aggregation
K Number
K954951Device Name
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
Manufacturer
Date Cleared
1996-05-30
(213 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TAYLOR INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Taylor TENS electrode is designed to be used in monitoring applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance, which can cause the pickup of 60 cycle neise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures. The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only.
Device Description
The Taylor TENS Electrode is intended to be used as an ECG or stimulating electrode. The electrode is a Silver/ Silver Chioride conductive coated carbon filled polymer, with an attached leadware. The adhesive that is being used is a hypo-allergenic hydrogel which allows for an adequate hold to the patient. This product meets all of the applicable AAM Standards.
Ask a Question
Ask a specific question about this device
Page 1 of 1