Xianhe TDP Infrared Therapy Lamp
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Basic Information
- Brand Name
- Xianhe TDP Infrared Therapy Lamp
- Primary DI
- B465CQ29II0
- Version / Model
- CQ-29II
- Catalog Number
- D-17
- 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
- 2017-09-08
- Public Version
- 5
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 6dad026d-95ef-4a11-90a8-f1c634c87c17
Device Description
The CQ-29II / D-17 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 infrared heat tubes 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. The CQ-29II 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.
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 | B465CQ29II0 | HIBCC |
Customer Contacts
- Phone
- 626-333-6686
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963728 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 25 | Pound | |
| Width | 24 | Inch | |
| Device Size Text, specify | Adjustable Min/Max Height: 33.5"/62" above floor |