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510(k) Data Aggregation
K Number
K140865Device Name
INFRARED HEATING DEVICE
Manufacturer
Date Cleared
2014-09-03
(153 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
PRO MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared Heating Device, Model PM-750, temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.
Device Description
The Infrared Heating Device, Model PM-750, is 110V AC powered, non-invasive, therapeutic medical device that provides continuous heat therapy through the use of infrared bulb. The device consists of a handle that houses the electronics and controls, and tungsten infrared bulb with light filter. The light filter is intended to be placed directly on the skin to provide topical heating. The infrared bulb is replaceable. The housing material is ABS.
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