Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770) → MNW — Analyzer, Body Composition # MNW · Analyzer, Body Composition _Cardiovascular · 21 CFR 870.2770 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW ## Overview - **Product Code:** MNW - **Device Name:** Analyzer, Body Composition - **Regulation:** [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. ## Classification Rationale Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Recent Cleared Devices (20 of 79) Showing 20 most recent of 79 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231116](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K231116.md) | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | Jun 15, 2024 | SESE | | [K140045](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K140045.md) | BODY COMPOSITION ANALYZER | Jawon Medical Co., Ltd. | Feb 18, 2015 | SESE | | [K141483](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K141483.md) | BIOSPACE BODY COMPOSITION ANALYZER | Biospace Corporation Limited | Sep 23, 2014 | SESE | | [K133872](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K133872.md) | ARIA WIFI SMART SCALE | Fitbit, Inc. | Jun 2, 2014 | SESE | | [K140594](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K140594.md) | BODY FAT ANALYZER AND SCALE | Conmo Electronic Company Limited | May 30, 2014 | SESE | | [K130856](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K130856.md) | BIA / VITALITY ANALYZER | Ipgdx, LLC | Nov 25, 2013 | SESE | | [K130777](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K130777.md) | INBODY | Biospace Corporation Limited | Nov 25, 2013 | SESE | | [K130952](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K130952.md) | PRECISION ONE LIFECARE; DETECTO; DETECTO | Precision One Lifecare, Ltd. | Sep 26, 2013 | SESE | | [K131394](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K131394.md) | TRANSTEK GLASS BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | Sep 18, 2013 | SESE | | [K130311](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K130311.md) | TRANSTEK BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | May 30, 2013 | SESE | | [K122388](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K122388.md) | SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 | Seca GmbH & Co. KG | May 2, 2013 | SESE | | [K123228](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K123228.md) | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) | Biospace Corporation Limited | Mar 8, 2013 | SESE | | [K123781](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K123781.md) | TRANSTEK GLASS BODY FAT ANALYZER | Zhongshan Transtek Electronics Co., Ltd. | Jan 9, 2013 | SESE | | [K122976](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K122976.md) | BODY FAT SCALE MODEL SF-371 | Shenzhen Belter Health Measurement and Analysis TE | Jan 4, 2013 | SESE | | [K121971](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K121971.md) | WITHINGS, SMART BODY SCALE | Zhongshan Transtek Electronics Co., Ltd. | Sep 27, 2012 | SESE | | [K120896](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K120896.md) | WI-FI BODY SCALE | Andon Health Co, Ltd. | Jul 26, 2012 | SESE | | [K121527](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K121527.md) | WI-FI BODY SCALE | Shenzhen Healthcare Electronic Technology Co., Ltd. | Jun 28, 2012 | SESE | | [K112149](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K112149.md) | WEIGHT AND BODY FAT SCALE SHINE BS0105 | Shine Overseas Marketing Limited | Apr 9, 2012 | SESE | | [K112951](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K112951.md) | BODY ANALYSIS SCALE | Shenzhen Healthcare Electronic Technology Co., Ltd. | Nov 1, 2011 | SESE | | [K112932](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW/K112932.md) | TRANSTEK | Zhongshan Transtek Electronics Co., Ltd. | Nov 1, 2011 | SESE | ## Top Applicants - Biospace Corporation Limited — 8 clearances - Bodystat , Ltd. — 7 clearances - Jawon Medical Co., Ltd. — 5 clearances - Omron Healthcare, Inc. — 4 clearances - Tanita Corp. of America — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MNW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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