FAQ (Frequently Asked Questions)
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GENERAL INFORMATION
Q: Is The EKG Glove™ FDA cleared for use in the United States?
Yes. The EKG Glove™ has 510K FDA clearance. It is a prescription only device
within the USA and it's territories.
Q: Does the have CE Marking approval for sale within the European
Union?
Yes. As of mid-February, 2012, The EKG Glove™ has it's CE Marking. No
prescription required to purchase The EKG Glove™ in the the countries that form
the European Union.
Q: Can The EKG Glove™ work with wireless and Wi-Fi integrated hospital
and emergency care systems?
Yes. The EKG Glove™ can connect to most standard ECG monitoring and recording
devices, including many of the newer wireless systems, using an approved,
compatible accessory cable. Click here for a list of cables and compatible
devices.