Identity
- Trade Name
- Xianhe Desktop TDP Infrared Therapy Lamp FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- The CQ-18 / D-05 TDP therapy lamp head contains 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 desk lamp with the control panel built into the base. The articulating arm allows you to easily position the emission head at different heights, while tilt and swivel head allows for multiple angles of treatment. FDA UDI
- Model / Reference
- CQ-18 FDA UDI
- Description
- The CQ-18 / D-05 TDP therapy lamp head contains 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 desk lamp with the control panel built into the base. The articulating arm allows you to easily position the emission head at different heights, while tilt and swivel head allows for multiple angles of treatment. FDA UDI
Identifiers
- Catalog Number
- D-05 FDA UDI
- Primary DI / UDI-DI
- B465CQ180 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
- Width — 24 Inch FDA UDIWeight — 25 Pound FDA UDI
Category: Musculoskeletal infrared phototherapy unit, non-wearable
Xianhe Desktop 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 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.
- 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 7115c062-db92-4bec-b87e-22d558c8ae86 37 fields · synced May 30, 2026