Search Results
Found 1 results
510(k) Data Aggregation
K Number
K131905Device Name
SOLID GEL PAD
Manufacturer
Date Cleared
2013-07-18
(22 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
BLUEMTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.
Device Description
The SOLID GEL PAD is ultrasound gel of the solid-state, generally used for ultrasound scanning for imaging diagnosis or ultrasound stimulator for treatment. The gel pad will be sold for single patient/procedure, disposable use. The SOLID GEL PAD is 9cm x 9cm aqueous, flexible. disposable ultrasound standoff for use in difficult to visualize and near field areas, or when gels alone won't do. Disposability eliminates the risk of cross contamination in diagnostic and therapeutic ultrasound procedures. It requires only gentle, even pressure. The SOLID GEL PAD is especially very useful for using ultrasound over areas that are bony such as fingers, hands, wrists, elbows, and ankles. It also allows visualization of superficial structures.
Ask a Question
Ask a specific question about this device
Page 1 of 1