Identity
- Trade Name
- Xianhe TDP Infrared Therapy Lamp FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CQ-29CN FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- D-11 FDA UDI
- Primary DI / UDI-DI
- B465CQ29CN0 FDA UDI
- 510(k) Number
- K963728 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 25 Pound FDA UDIWidth — 24 Inch FDA UDI
Category: Musculoskeletal infrared phototherapy unit, non-wearable
Xianhe TDP Infrared Therapy Lamp by A & A Medical Supplies Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K963728 also covers:
- Xianhe Desktop TDP Infrared Therapy Lamp — A & A Medical Supplies Co.
- Xianhe Double-Headed TDP Infrared Therapy Lamp — A & A Medical Supplies Co.
- Xianhe TDP Infrared Therapy Lamp — A & A Medical Supplies Co.
- Xianhe TDP Infrared Therapy Lamp — A & A Medical Supplies Co.
- Xianhe TDP Infrared Therapy Lamp — A & A Medical Supplies Co.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- A & A Medical Supplies Co.
Sources (1)
- FDA UDI c8b072b6-99b8-45aa-9f27-943dceb67097 37 fields · synced May 30, 2026