FDA UDI
In Commercial Distribution
🇺🇸 United States
HuBDIC Leg Massager
DI: 06975977230023
·
Model: MD-100
·
Dongguan City Umed Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HuBDIC Leg Massager
- Primary DI
- 06975977230023
- Version / Model
- MD-100
- Company Name
- Dongguan City Umed Technology Co., Ltd
- Labeler DUNS
- 602090959
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-10
- Public Version
- 1
- Public Version Date
- 2023-08-18
- Public Version Status
- New
- Public Device Record Key
- 9e0ce35b-fe38-4d31-85bd-67ea0771a233
Device Description
The product is composed of built-in rechargeable lithium battery, air pump, control valve, massage air bag and hot compress. It is used to massage the human calf, which can relieve leg fatigue, improve leg blood circulation and prevent varicose veins.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
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 | 16975977230020 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 06975977230023 | GS1 |