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510(k) Data Aggregation
K Number
K964523Device Name
RECOVER INFANT HEEL WARMER (5100)
Manufacturer
FLORIDA MEDICAL INDUSTRIES, INC.
Date Cleared
1997-02-10
(90 days)
Product Code
MPO
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
FLORIDA MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.
Device Description
Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.
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K Number
K963689Device Name
RECOVER ADULT VEIN WARMER
Manufacturer
FLORIDA MEDICAL INDUSTRIES, INC.
Date Cleared
1996-12-12
(87 days)
Product Code
IMD
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
FLORIDA MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Recover® Instant Heat Therapy Pack is intended for use with conditions that indicate the use of heat therapy.
Device Description
Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon bag. Provides heat to 112ºF.
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