AccessGUDID - DEVICE: Xianhe Double-Headed TDP Infrared Therapy Lamp (B465CQ360)

GUDID

Device Identifier (DI) Information

Brand Name: Xianhe Double-Headed TDP Infrared Therapy Lamp
Version or Model: CQ-36
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D-04B
Company Name: A & A MEDICAL SUPPLIES INC.

Primary DI Number: B465CQ360
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801197380 *Terms of Use

Device Description: The CQ-36 / D-04B TDP therapy lamp has two independent emission heads, each containing 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 free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the articulating arms, each emission head can be positioned as low as 12" to as high as 52" from the floor. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35147	Musculoskeletal infrared phototherapy unit, non-wearable	An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963728	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 25 Pound
Width: 24 Inch
Device Size Text, specify: Adjustable Min/Max Height: 33.5"/62" above floor

Device Record Status

Public Device Record Key: 0d370df7-e9f1-4ce1-8b03-2c658a6421c6
Public Version Date: April 18, 2025
Public Version Number: 5
DI Record Publish Date: May 23, 2017