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510(k) Data Aggregation
K Number
K092364Device Name
MODEL 220 PATIENT MAGNET
Manufacturer
Date Cleared
2009-11-03
(90 days)
Regulation Number
870.3690Why did this record match?
Product Code :
DTG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The patient magnet is used to close the reed switch of a pulse generator when held above the reed switch, 1 inch from the generator's surface, and oriented with the magnet's axis parallel to the longitudinal axis of the reed switch.
Device Description
The patient magnet is used daily to check that the pulse generator battery is working. When you pass or hold the magnet over the pulse generator, a reed switch inside the pulse generator closes like a gate. When the magnet closes the switch, the normal signal (stimulation) cannot pass, and the pulse generator is temporarily turned OFF. When the magnet is removed, the switch (gate) opens immediately, and the pulse generator is turned back ON and can stimulate again.
The patient magnets are made from Neodymium grade 35 (NdFeB-35) and the entire surface of the magnet is coated with either polypropylene copolymer. The magnet is 1.48 in. x 0.195 in; 50 gauss (G) minimum magnetic flux density at a distance of 1 inch from its surface. Also supplied with Patient Magnet, are a watchband and a belt-clip that allows that patient to wear the magnet on the wrist like a watch or clipped on belt like a pager for easy deployment.
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K Number
K960849Device Name
MAGNO ALARM
Manufacturer
Date Cleared
1997-03-26
(400 days)
Product Code
Regulation Number
870.3690Why did this record match?
Product Code :
DTG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
useful, safe and effective for forewarning presence of environmental magnetic fields that might be potentially harmful for certain individuals with implanable devices such as pacemakers or ICD's.
Device Description
a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it.
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