TDP CQ-55A Heat Lamp

Basic Information

• Brand Name: TDP CQ-55A Heat Lamp
• Primary DI: 16970469760047
• Version / Model: RY3847
• Catalog Number: RY3847
• Company Name: CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
• Labeler DUNS: 526910796
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-20
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ea6347e5-4fd0-4835-8e34-40c367061eb0

Device Description

The TDP CQ-55A heat lamp is unlike any other heat lamp. While most lamps use a common infrared bulb, the specially engineered TDP CQ-55A 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)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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	A mains electricity (AC-powered) device intended 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	16970469760047	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043558	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Range: 24" vertical, 24" horizontal Min/Max Height: 23" to 60" above floor
Weight	25	Pound