FDA UDI
In Commercial Distribution
🇺🇸 United States
CuPiLO
DI: 06953825909871
·
Model: UM605
·
Shenzhen Urion Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CuPiLO
- Primary DI
- 06953825909871
- Version / Model
- UM605
- Company Name
- Shenzhen Urion Technology Co., Ltd
- Labeler DUNS
- 421294358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-13
- Public Version
- 1
- Public Version Date
- 2025-06-23
- Public Version Status
- New
- Public Device Record Key
- fce8eb35-aaca-4abd-af61-e6cf3a6218cb
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
- 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 |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34489 | Pneumatic massager | An pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16953825909878 | GS1 | Carton | 18 | In Commercial Distribution | |
| Primary | 06953825909871 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250046 | 000 |