FDA UDI
In Commercial Distribution
🇺🇸 United States
DPL
DI: 00857563004965
·
Model: ZLD-60SA
·
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DPL
- Primary DI
- 00857563004965
- Version / Model
- ZLD-60SA
- Catalog Number
- N.A.
- Company Name
- LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
- Labeler DUNS
- 854329477
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-10
- Public Version
- 1
- Public Version Date
- 2022-02-18
- Public Version Status
- New
- Public Device Record Key
- 81028e37-249f-4621-b1c8-83d0f19ed138
Device Description
Red and Infra-Red LED Light Therapy Pad for Pain Relief.
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
- 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 |
|---|---|---|---|---|
| 63381 | Musculoskeletal infrared phototherapy unit, wearable | A patient-worn, battery-powered device assembly intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., joint pain), and to improve blood circulation in these areas. It consists of a device with an integrated light with a controller; the light is intended to be attached to a specific body part (e.g., back, knee) and may include devices (e.g., adhesive pad) to allow attachment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857563004965 | GS1 |