FDA.reportPublic FDA data

WS Far Infrared Therapy Unit

Primary DI
04719873220199
Brand
WS Far Infrared Therapy Unit
Company
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
Model
KP-B210
Device description
The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 μm Far-infrared energy through Far Infrared (FIR)radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
Published
2017-10-06
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
K160849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160849000WS(TM) Far-Infrared Therapy Unit, Model KP-B210Ws Far IR Medical Technology Co., Ltd.2016-12-15ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873220199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873220199047198732201994719873220199

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 Celsius30 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius50 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
04719873220045WS Far Infrared Therapy UnitTY-101F2016-11-01

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