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510(k) Data Aggregation
K Number
K101894Device Name
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
Manufacturer
Date Cleared
2011-01-21
(198 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
BIOREMEDI THERAPEUTIC SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HealthLight™ MicroController, MiniPro, ProNeurolLght, and Pro Unit are intended for the following indications for use:
1. Provides heat therapy, i.e., temporarily relieves minor pain, stiffness and muscle spasm.
2. Temporarily increases local blood circulation.
It is an Rx Only medical device.
Device Description
The BioRemedi HealthLight™ is a scalable system consisting of seven different shaped/sized pads holding LEDs that may be used with any of three controllers, the differences being a two, a three or a four port configuration. Any pad, alone, or in any combination with any other pad, may be used with any of these three controllers.
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