Duns Number:526910796
Device Description: The TDP CQ-27 heat lamp is unlike any other heat lamp. While most lamps use a common infra The TDP CQ-27 heat lamp is unlike any other heat lamp. While most lamps use a common infrared bulb, the specially engineered TDP CQ-36 features a "black body" emission heating plate which is coated with a proprietary mineral formulation consisting of 33 elements. When activated by a built-in electric heating element, this mineral plate emits a special band of far infrared electromagnetic energy which penetrates deep into the human body. The human body (cells) has a higher absorption efficiency for far infrared energy than near infrared. The emission head can be positioned as low as 12" (for treating feet) to 60". Depending on the treated condition, repeated treatments of 20 to 40 minutes are recommended. Easy assembly. Floor model, 5-point base with casters. UL approved. Has continuous ON or 60-minute timer. Treatment distance is 8” to 18” (20 to 46 cm). Main post telescopes 12”; device head tilts up to 90 degrees and rotates 360 degrees. Warranty: 90 days (parts and labor), 1 year(parts)
Catalog Number
RY3364
Brand Name
TDP CQ-27 Heat Lamp
Version/Model Number
RY3364
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
a931bee1-37cb-4e3c-aed3-0f80316fa708
Public Version Date
May 08, 2018
Public Version Number
3
DI Record Publish Date
July 20, 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. | 4 |