Data / Medical devices / Analyzer, Body Composition
Analyzer, Body Composition (MNW): 26 FDA-registered makers in 8 countries
26 establishments in 8 countries are registered with the FDA to make Analyzer, Body Composition (product code MNW, Class 2, 21 CFR 870.2770). 20 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 79 510(k) clearances under this code, the latest on June 15, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MNW
- Device class
- 2
- Regulation
- 870.2770
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| China | 11 |
| United States | 6 |
| Japan | 3 |
| South Korea | 2 |
| Isle of Man | 1 |
| Australia | 1 |
| Hong Kong | 1 |
| Germany | 1 |
Makers of Analyzer, Body Composition
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Tanita Corp. | ITABASHI-KU Tokyo, Japan | Specification developer | 7 | April 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Tanita Corporation of Akita, Ltd | Daisen City Akita, Japan | Manufacturer | 7 | April 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Bodystat Ltd | Isle of Man, Isle of Man | Manufacturer | 4 | February 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Tanita Health Equipment Co., Ltd. | Dongguan City Guangdong, China | Manufacturer | 4 | July 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| InBody Co, Ltd. | Cheonan-si Chungnam, South Korea | Manufacturer | 4 | September 23, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Healthcare Electronic Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 3 | June 28, 2012 | 0 | 0 | 0 | api.fda.gov |
| Higi SH LLC | Chicago, IL, United States | Specification developer | 2 | January 26, 2011 | 0 | 0 | 0 | api.fda.gov |
| Impedimed Limited | Lindfield New South Wales, Australia | Manufacturer | 2 | April 4, 2006 | 0 | 0 | 0 | api.fda.gov |
| SELVAS Healthcare, Inc. | Yuseong-gu Daejeon, South Korea | Manufacturer | 2 | February 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Cha's Electronic Industries (shenzhen) Company Limited | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 1 | May 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| Conmo Electronic Company Limited | Huizhou City Guangdong, China | Contract manufacturer, Manufacturer | 1 | May 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Fitbit LLC | San Francisco, CA, United States | Manufacturer | 1 | June 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| Fook Tin Technologies Limited | Quarry Bay, Hong Kong | Manufacturer, Specification developer | 1 | May 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| LD Technology LLC | Miami, FL, United States | Specification developer | 1 | March 29, 2011 | 0 | 0 | 0 | api.fda.gov |
| Omron Healthcare Co., Ltd. | MUKO Kyoto, Japan | Specification developer | 1 | November 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Seca | Hamburg, Germany | Manufacturer | 1 | May 2, 2013 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | January 4, 2013 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Shine Industrial Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | April 9, 2012 | 0 | 0 | 0 | api.fda.gov |
| Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | Zhongshan Guangdong, China | Manufacturer | 1 | June 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zhongshan Transtek Electronics Co., Ltd | Zhongshan Guangdong, China | Contract manufacturer, Manufacturer | 1 | May 30, 2013 | 0 | 0 | 0 | api.fda.gov |
| Andon Health Co., Ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Csa Service Solutions, LLC | Wilmington, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Impedimed, Inc. | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Krell Precision (yangzhou) Co., Ltd | YANGZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Measurement Ltd. | Kowloon City, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OnCore Manufacturing | Westborough, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.