AccessGUDID - DEVICE: WS Far Infrared Therapy Unit (04719873220045)

GUDID

Device Identifier (DI) Information

Brand Name: WS Far Infrared Therapy Unit
Version or Model: TY-101F
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WS FAR IR MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 04719873220045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656915154 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37327	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).	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080465	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c24b1582-51d8-4ba8-85ad-e37d021bcbe8
Public Version Date: October 12, 2020
Public Version Number: 5
DI Record Publish Date: November 01, 2016