Identity
- Trade Name
- Xianhe TDP Infrared Therapy Lamp FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CQ-27 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- D-04 FDA UDI
- Primary DI / UDI-DI
- B465CQ270 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 2a31130c-cc17-46da-83a0-cf759c42c99a 37 fields · synced May 31, 2026