Xianhe TDP Infrared Therapy Lamp - The CQ-29CN / D-11 TDP infrared therapy lamp - A & A MEDICAL SUPPLIES INC.

Duns Number:801197380

Device Description: The CQ-29CN / D-11 TDP infrared therapy lamp contains a mineral plate consisting of 33 ele The CQ-29CN / D-11 TDP infrared therapy lamp contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating coil in the TDP lamp head, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed.A digital control panel with a back-lit LCD screen is located on the stand. Get precise controls over different aspects of treatment. Set treatment duration with the built-in timer by pressing the Timing button—adjustable from 30-60 minutes in 5 minute increments. Power level is also adjustable by pressing Adjustment button to set power from 50-100% in 10% increments. The LCD display is large and clear giving you all the information you need at a glance. The CQ-29CN lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the telescoping main post and articulating neck, the emission head can be positioned as low as 21" to as high as 61" from the floor with the post fully extended. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.

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More Product Details

Catalog Number

D-11

Brand Name

Xianhe TDP Infrared Therapy Lamp

Version/Model Number

CQ-29CN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

c8b072b6-99b8-45aa-9f27-943dceb67097

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 08, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"A & A MEDICAL SUPPLIES INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6