FDA UDI
In Commercial Distribution
🇺🇸 United States
ZOOM WELLNESS
DI: 06973351910028
·
Model: QY-S-BD-A
·
Kinreen Technology (Shenzhen) Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- ZOOM WELLNESS
- Primary DI
- 06973351910028
- Version / Model
- QY-S-BD-A
- Company Name
- Kinreen Technology (Shenzhen) Co., Ltd
- Labeler DUNS
- 554534919
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2020-07-02
- Public Version
- 2
- Public Version Date
- 2020-07-24
- Public Version Status
- Update
- Public Device Record Key
- 44d182b8-6fb5-4ec7-9204-4931ba881c78
Device Description
The red light therapy bulb is made of red 660nm and near infrared 850nm which produces a wide range of health benefits . What’s Included : 1* Luxx Bulb 1* Remote Control 1* Power Clip Stand 1* Instruction Manual Insert the bulb into the power clip just like an ordinary light bulb , plug the bulb into the nearest wall socket than enjoy your red light at home . No need go to clinic and money – saving .
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 | A mains electricity (AC-powered) device intended 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 | 06973351910028 | GS1 | ||||
| Unit of Use | 16973351910025 | GS1 |