Body Composition Analyzer
FDA 510(k) K140045 · Jawon Medical Co., Ltd.
510(k) numberK140045
Submission
- Device name
- Body Composition Analyzer
- Applicant
- Jawon Medical Co., Ltd.
Kyungsan-City, Kyungsan-Bukdo, KR - Received
- January 8, 2014
- Decision date
- February 18, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNW – Analyzer, Body Composition
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
Other 510(k)s with product code MNW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231116 | Multi-parameter detectorMNW · Traditional | Zhongshan Jinli Electronic Weighing Equipment… | 06/15/2024SE |
| K141483 | Biospace Body Composition AnalyzerMNW · Traditional | Biospace Corporation Limited | 09/23/2014SE |
| K133872 | Aria Wifi Smart ScaleMNW · Traditional | Fitbit, Inc. | 06/02/2014SE |
| K140594 | Body Fat Analyzer and ScaleMNW · Traditional | Conmo Electronic Company Limited | 05/30/2014SE |
| K130856 | Bia / Vitality AnalyzerMNW · Traditional | Ipgdx, LLC | 11/25/2013SE |
| K130777 | InbodyMNW · Traditional | Biospace Corporation Limited | 11/25/2013SE |
| K130952 | Precision One Lifecare; Detecto; DetectoMNW · Traditional | Precision One Lifecare, Ltd. | 09/26/2013SE |
| K131394 | Transtek Glass Body Fat AnalyzerMNW · Special | Guangdong Transtek Medical Electronics Co., Ltd. | 09/18/2013SE |
| K130311 | Transtek Body Fat AnalyzerMNW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 05/30/2013SE |
| K122388 | Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514MNW · Traditional | Seca GmbH & Co. KG | 05/02/2013SE |
More from Seca GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K140762 | Automatic Blood Pressure MonitorDXN · Traditional | 07/02/2015SE |
| K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L)DXN · Special | 10/09/2009SE |
| K092431 | Body Composition Analyzer, Model: Ioi 353MNW · Special | 10/08/2009SE |
| K072325 | Body Composition Analyzer, Easybody 202, 203, 205MNW · Traditional | 11/30/2007SE |
| K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia…MNW · Special | 08/09/2007SE |
| K062462 | Non-Invasive Blood Pressure Monitor, Models FT-500R/L and FT-700R/LDXN · Traditional | 09/29/2006SE |
| K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5MNW · Traditional | 08/31/2006SE |
| K013876 | Infrared Ear Thermometer, Model DX-707FLL · Traditional | 03/04/2002SE |
| K002722 | Digital Blood Pressure Monitor, Models HD-503 and HD-505DXN · Special | 09/11/2000SE |
| K000675 | Manual Digital Blood Pressure Monitor, Model HD-502DXN · Traditional | 03/14/2000SE |
Questions and answers
When was Body Composition Analyzer cleared by the FDA?
Body Composition Analyzer (K140045) received a 510(k) decision of Substantially Equivalent on February 18, 2015, 406 days after the submission was received.
What is the product code of K140045?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.