Duns Number:554534919
Device Description: The red light therapy bulb is made of red 660nm and near infrared 850nm which produces a w The red light therapy bulb is made of red 660nm and near infrared 850nm which produces a wide range of health benefits . What’s Included : 1* Luxx Bulb1* Remote Control 1* Power Clip Stand 1* Instruction Manual Insert the bulb into the power clip just like an ordinary light bulb , plug the bulb into the nearest wall socket than enjoy your red light at home . No need go to clinic and money – saving .
Catalog Number
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Brand Name
ZOOM WELLNESS
Version/Model Number
QY-S-BD-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
44d182b8-6fb5-4ec7-9204-4931ba881c78
Public Version Date
July 24, 2020
Public Version Number
2
DI Record Publish Date
July 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-