Product Information
FDA 510(k) Application Details - K033559
Device classification Name: Electrode, Electrocardiogralh
510(K) Number: K033559
Device Name: 12-LEAD GLOVE
Applicant: INEEDMD
Regulation Number: 21 CFR 87.2360
Classification Product Code: DRX
Date received: 11/12/2003
Decision date: 12/22/2004
Decision: SE - Substantially Equivalent
Classification Advisory Committee: CV - Cardiovascular
Review Advisory Committee: CV - Cardiovascular
FDA 510(k) Application Details - K112123
Device classification Name: Electrode, Electrocardiogralh
510(K) Number: K112123
Device Name: 12-LEAD GLOVE
Applicant: INEEDMD
Regulation Number: 21 CFR 87.2360
Classification Product Code: DRX
Date received: 07/25/2011
Decision date: 08/12/2011
Decision: SE - Substantially Equivalent
Classification Advisory Committee: CV - Cardiovascular
Review Advisory Committee: CV - Cardiovascular
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Directions
The recording of an ECG using The EKG Glove System requires a second person or a medical assistant to first open the sealed pouch containing one disposable EKG Glove.
Following patient preparation (e.g., shaving the chest area on a hairy patient), the person or medical assistant places his or her right hand into The EKG Glove and peels off a protective layer from one side of The EKG Glove, thereby exposing the 10 electrodes embedded in The EKG Glove.
The person or medical assistant stands on the right side of the prone patient and places his or her hand over the chest of the patient, adhesive side down, in an orientation which is depicted in a diagram on the back of the glove/mitten and is explained in the package insert.
After the glove/mitten has been applied to the chest, the person or medical assistant removes his or her hand from within The EKG Glove, because the adhesive on the electrodes enables The EKG Glove to remain positioned properly.
Three electrodes on The EKG Glove are designed to be placed in specific positions on the patient's chest, one each under the right and left collar bone and the third on the lower end of the left ribcage. These extendable electrodes can be easily picked up and put in place without effort. The right arm (RA), left arm (LA), left leg (LL) are properly marked on these extendable electrodes. Notably, no electrodes need to be applied to the patient's arms or legs and no conductive gel needs to be applied separately by the person or medical assistant.
The EKG (ECG) Glove is designed for consistent placement of electrodes to reduce time, and thus costs, in the physician's office and in hospital settings. As mentioned previously, The EKG Glove is disposable after one use, the algorithm box and the cable are not.