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510(k) Data Aggregation
K Number
K033559Device Name
12-LEAD GLOVE
Manufacturer
Date Cleared
2004-12-22
(406 days)
Product Code
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
INEEDMD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.
Device Description
The 12-Lead Glove has been designed to obtain an electrocardiogram (ECG) with pre-positioned electrodes affixed to the underside of a glove-like sheath. The pre-printed conductive circuity is contained within the sheath (or shell) on a flexible substrate. To obtain the tracing, the operator need only connect the glove via a single (multi-conductor) cable connected to the ECC monitor, slip on the glove, position their hand on the patient's chest, and attach three extendable electrodes which will provide a full 12-Lead recording. The 12-Lead Glove saves valuable time required for set-up compared to the standard approach with multiple electrode placements. It eliminates the confusion of working with the standard cables and eliminates erroneous ECG readings.
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