Duns Number:656915154
Device Description: The WS Therapy Unit is an infrared heating system which emits topical heat to the human bo 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.
Catalog Number
-
Brand Name
WS Far Infrared Therapy Unit
Version/Model Number
TY-101F
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080465
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |