Identity
- Trade Name
- ZOOM WELLNESS FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- 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 . FDA UDI
- Model / Reference
- QY-S-BD-A FDA UDI
- 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 . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973351910028 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Musculoskeletal infrared phototherapy unit, non-wearable
Zoom Wellness by Kinreen Technology (Shenzhen) Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Kinreen Technology (Shenzhen) Co., Ltd
Sources (1)
- FDA UDI 44d182b8-6fb5-4ec7-9204-4931ba881c78 33 fields · synced Jun 8, 2026