Xianhe TDP Infrared Therapy Lamp

Basic Information

• Brand Name: Xianhe TDP Infrared Therapy Lamp
• Primary DI: B465CQ270
• Version / Model: CQ-27
• Catalog Number: D-04
• Company Name: A & A MEDICAL SUPPLIES INC.
• Labeler DUNS: 801197380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-23
• Public Version: 5
• Public Version Date: 2025-04-18
• Public Version Status: Update
• Public Device Record Key: 2a31130c-cc17-46da-83a0-cf759c42c99a

Device Description

The CQ-27 / D-04 TDP lamp provides penetrating heat therapy to elevate tissue temperature, temporarily increase local blood circulation, and temporarily relieve minor muscle and joint pain and stiffness. The head contains a mineral plate consisting of 33 elements essential to the human body. As this mineral plate is activated by a built-in heating element in the TDP lamp, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed. The CQ-27 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B465CQ270	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K963728	000

Device Sizes

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