DEVICE: WS Far Infrared Therapy Unit (04719873220045)

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Device Identifier (DI) Information

WS Far Infrared Therapy Unit
TY-101F

WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
04719873220045
GS1
1
The WS Therapy Unit is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3~25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net on the emitter to prevent fire or direct touch by the user. The entire unit is mounted on the base that is easy to move. The device uses 100V as the power source. It meets the related requirement of IEC60601-1 Electrical Safety.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Full-body radiant heating system An assembly of mains electricity (AC-powered) devices consisting of an infrared (IR) heating element-containing device designed to emit controlled, evenly distributed heat from above to the full-length of a horizontally-placed adult patient's body requiring a regulated thermal environment and a control unit used to regulate the intensity and the location (full body or specific body region) of heat from the overhead canopy heat source. This device is typically used in, e.g., a burn unit or an intensive care unit (ICU).
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FDA Product Code

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Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -15 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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