FDA UDI
In Commercial Distribution
🇺🇸 United States
Xianhe Desktop TDP Infrared Therapy Lamp
DI: B465CQ180
·
Model: CQ-18
·
A & A MEDICAL SUPPLIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Xianhe Desktop TDP Infrared Therapy Lamp
- Primary DI
- B465CQ180
- Version / Model
- CQ-18
- Catalog Number
- D-05
- 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
- 7115c062-db92-4bec-b87e-22d558c8ae86
Device 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.
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 | B465CQ180 | HIBCC |
Customer Contacts
- Phone
- 626-333-6686
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963728 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Adjustable Min/Max Height: 33.5"/62" above floor | ||
| Width | 24 | Inch | |
| Weight | 25 | Pound |