Fat Loss Monitor
Omron Fat Loss Monitor
11manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (8), Tianjin (1), Jiangsu (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhongshan Transtek Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 5 |
| Conmo Electronic Company Limited | Huizhou | Guangdong | Contract manufacturer | 4 |
| Krell Precision (Yangzhou) Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 4 |
| Cha’s Electronic Industries (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Measurement Ltd. | Kowloon City | Contract manufacturer | 1 | |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 6 |
| Shenzhen Healthcare Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Dongguan Tanita Health Equipment Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
| Shenzhen Shine Industrial Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Omron Healthcare, Inc., United States |
|---|---|
| FDA product code | MNW |
| Device type | Analyzer, Body Composition |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K011652 |
| Record published | 2016-09-16 |
| Record revised | 2025-06-04 (version 4) |
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 temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment humidity 10 to 95 % RH; Handling environment humidity 30 to 85 % RH; Handling environment temperature 10 to 40 °C; Handling environment temperature 50 to 104 °F |
| Packaging | Inner carton of 3, case of 4 |
| Distribution end date | 2025-06-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HBF-306CN | Withdrawn | |
| HBF-306CAN | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conair | Conair LLC. | 38 |
| Taylor | Taylor Precision Products, Inc. | 32 |
| InBody | InBody Co., Ltd. | 16 |
| Weight Gurus | Greater Goods, LLC | 12 |
| TANITA/Ironman Body Composition Monitor | Tanita International Ltd. | 8 |
| Detecto | Lifespan Brands LLC | 7 |
| Health-O-Meter | Jarden Consumer Solutions | 6 |
| Tanita Body Composition Analyzer | Tanita International Ltd. | 6 |
| Analyzer,Body composition | Shenzhen Unique Scales Co., Ltd. | 6 |
| Imp DF50 | Impedimed Limited | 6 |
| Imp SFB7 | Impedimed Limited | 6 |
| TANITA/FitScan Body Composition Monitor | Tanita International Ltd. | 5 |
Showing 12 of 63. All products under Analyzer, Body Composition
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062043 | 2006-11-07 |
| K043060 | 2005-01-19 |
| K011652 | 2001-11-07 |
| K963575 | 1997-06-13 |
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.