Viva 360+ Smart Scale
VIVA 360+ Smart Scale is intended to be used to calculate and display the estimated value of body fat percentage, subcutaneous fat percentage, skeletal muscle percentage, resting…
VIVA 360+ Smart Scale is intended to be used to calculate and display the estimated value of body fat percentage, subcutaneous fat percentage, skeletal muscle percentage, resting metabolism, body water percentage, bone mass, fat free mass and visceral fat levels using the BI (Bioelectrical Impedance) method and indicates the BMI (Body Mass Index). The VIVA 360+ Smart Scale is intended to be used by healthy individuals in the age range of 18 to 80 years for the subcutaneous fat percentage and visceral fat level. The age range for body fat percentage, skeletal muscle percentage, resting metabolism, body water percentage, bone mass and fat free mass are intended to be used by healthy individuals between the age of 6 to 80 years. The device is intended for multiple-patient, multiple-use
Who Else Makes It
Concentrated in Guangdong (23), Jiangsu (4), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Shenzhen AOJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Chartek Electronic (Yang Zhou) Ltd | Yangzhou City, Jiansu | Jiangsu | Contract manufacturer | 6 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Conmo Electronic Company Limited | Huizhou | Guangdong | Contract manufacturer | 4 |
| Shenzhen Yolanda Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Krell Precision (Yangzhou) Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 4 |
| Guangdong Xinyu Electronic AND Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Unique Scales Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Ningbo Unico Products Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
Showing 12 of 36. All 36 manufacturers in China registered for Analyzer, Body Composition, Exempt
Record
| Listed by | Omron Healthcare, Inc., United States |
|---|---|
| FDA product code | PUH |
| Device type | Analyzer, Body Composition, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-16 |
| Record revised | 2026-07-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment atmospheric pressure 70 to 160 KiloPascal; Handling environment humidity 10 to 95 % RH; Storage environment temperature -20 to 60 °C; Handling environment temperature 50 to 104 °F; Storage environment temperature -4 to 140 °F; Handling environment temperature 10 to 40 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BCM-750 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Body Composition Scale | Guangzhou Daxin Health Technology Co., Ltd. | 45 |
| Charder | Charder Electronic Co., Ltd. | 41 |
| Anovator | Wuhan Zhaike Network Technology Company, Limited | 20 |
| Etekcity Smart Fitness Scale | Vesync (US) Corporation | 16 |
| Renpho Body Composition Scale | Joicom Corporation | 13 |
| Meicet | Shanghai MAY Skin Information Technology Co., Ltd. | 12 |
| Withings® | Withings | 12 |
| Renpho | Joicom Corporation | 12 |
| Renpho Smart scale | Joicom Corporation | 11 |
| InBody | InBody Co., Ltd. | 10 |
| Beurer | Beurer North America, L.P. | 10 |
| RJL Quantum | R.J.L. Sciences, Inc. | 9 |
Showing 12 of 119. All products under Analyzer, Body Composition, Exempt
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.