Duns Number:801197380
Device Description: The CQ-18 / D-05 TDP therapy lamp head contains a mineral plate consisting of 33 elements The CQ-18 / D-05 TDP therapy lamp head contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating element begins to emit FIR (far infrared) waves along with the ionized minerals which easily penetrates deep into the body to be absorbed.The CQ-36 lamp is a desk lamp with the control panel built into the base. The articulating arm allows you to easily position the emission head at different heights, while tilt and swivel head allows for multiple angles of treatment.
Catalog Number
D-05
Brand Name
Xianhe Desktop TDP Infrared Therapy Lamp
Version/Model Number
CQ-18
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K963728
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
7115c062-db92-4bec-b87e-22d558c8ae86
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 23, 2017
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. | 6 |