FDA UDI
In Commercial Distribution
🇺🇸 United States
Homedics
DI: 00031262102720
·
Model: FB-50J-BL
·
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Homedics
- Primary DI
- 00031262102720
- Version / Model
- FB-50J-BL
- Company Name
- Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
- Labeler DUNS
- 544356011
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-01
- Public Version
- 1
- Public Version Date
- 2021-03-09
- Public Version Status
- New
- Public Device Record Key
- 10648385-87f5-4e7f-916d-f1bcc96e9c05
Device Description
BUBBLE BLISS DELUXE FOOTBATH
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 36557 | Foot bath | A mains electricity (AC-powered) device designed to be filled with water to provide therapeutic heat treatment specifically to the feet. It typically consists of a unit with a wide stable base that stands on the floor and includes a shallow receptacle in the centre for the user to place their feet. It has a heating element with thermostat that heats the water to a selected temperature. Some types may have therapeutic foot massage capabilities. This device is intended to relieve foot pain (e.g., ankle joint pain from sprains), as well as headaches, coughs, and other cold symptoms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00031262102720 | GS1 |