FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Body Fat Analyzer
DI: 06928812600062
·
Model: FG850L
·
GUANGDONG WELLAND TECHNOLOGY CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Body Fat Analyzer
- Primary DI
- 06928812600062
- Version / Model
- FG850L
- Company Name
- GUANGDONG WELLAND TECHNOLOGY CO.,LTD
- Labeler DUNS
- 543350403
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-17
- Public Version
- 2
- Public Version Date
- 2020-01-01
- Public Version Status
- Update
- Public Device Record Key
- 587c815b-2f82-4992-bf78-edb1c345febf
- Distribution End Date
- 2020-01-01
Device Description
This device is intened to be used for determining body weight and analyzing the proportion of water and body fat as well as proportion of muscle and bone mass in the body, and for calculating the body mass index (BMI).
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
- Yes
- 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 |
|---|---|---|---|---|
| PUH | Analyzer, Body Composition, Exempt | Cardiovascular | 870.2770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36022 | Bioelectrical body composition analyser | An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06928812600062 | GS1 |