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510(k) Data Aggregation
K Number
K190899Device Name
bili-hut
Manufacturer
Little Sparrows Technologies, Inc.
Date Cleared
2019-09-05
(150 days)
Product Code
LBI
Regulation Number
880.5700Why did this record match?
Applicant Name (Manufacturer) :
Little Sparrows Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The bill-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.
Device Description
The bili-hut™ is a modular, portable blue LED-based phototherapy device intended to treat neonatal hyperbilirubinemia, commonly known as infant jaundice. The bili-hut™ consists of the assembled hut (shell with light source, base mattress, base), nest components (nest, nest liner, nest mattress, nest mattress cover), and power supply. It has an optional accessory, the perch, which is a bassinet stand insert. Features include a timer for total LED use and an Environment High Temperature Warning with automatic shutoff. The principle of operation is phototherapy using blue light to break down bilirubin. The device is powered by a 12V medical grade power supply and uses an LED light array. The materials include fabric-based, plastic, metal, and electronic components.
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