FDA.reportPublic FDA data

WS Far Infrared Therapy Unit

Primary DI
04719873220045
Brand
WS Far Infrared Therapy Unit
Company
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
Model
TY-101F
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.
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080465000WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIESWs Far IR Medical Technology Co., Ltd.2008-07-18ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873220045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873220045047198732200454719873220045

GMDN Terms#

Term, Definition table
TermDefinition
Full-body radiant heating systemAn 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656915154
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873220199WS Far Infrared Therapy UnitKP-B2102017-10-06

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Primary DI, Brand, Company table
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