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510(k) Data Aggregation
K Number
K183148Device Name
OKLand Patient Return Electrode Pad
Manufacturer
Auckland Medical Polymer(Tianjin) Co., Ltd.
Date Cleared
2020-02-04
(448 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Auckland Medical Polymer(Tianjin) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OKLand Patient Return Electrode Pad is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery.
This device is restricted to use with isolated monopolar electrosurgical generators, not intended for radio frequency ablation.
Device Description
The device consists of a layer of conductive Copper-Nickel fibbers-coated polyester mesh, encased in a viscoelastic and dielectric polyurethane (PU) gel. These two materials are wrapped and sealed with PU membrane. A (or two) BVR lead (s) is attached outside of the pad, one side of the lead is connected to the conductive mesh, and the other side of the lead is assembled with different kinds of connectors.
This device should be operated by qualified healthcare personnel and is intended to be used for patients with a body weight no less than 0.35 kg (0.81b). , with no upper body weight limit.
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