MNW · Analyzer, Body Composition
Cardiovascular · 21 CFR 870.2770 · Class 2
Overview
| Product Code | MNW |
|---|---|
| Device Name | Analyzer, Body Composition |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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 | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | Jun 15, 2024 | SESE |
| K140045 | BODY COMPOSITION ANALYZER | Jawon Medical Co., Ltd. | Feb 18, 2015 | SESE |
| K141483 | BIOSPACE BODY COMPOSITION ANALYZER | Biospace Corporation Limited | Sep 23, 2014 | SESE |
| K133872 | ARIA WIFI SMART SCALE | Fitbit, Inc. | Jun 2, 2014 | SESE |
| K140594 | BODY FAT ANALYZER AND SCALE | Conmo Electronic Company Limited | May 30, 2014 | SESE |
| K130856 | BIA / VITALITY ANALYZER | Ipgdx, LLC | Nov 25, 2013 | SESE |
| K130777 | INBODY | Biospace Corporation Limited | Nov 25, 2013 | SESE |
| K130952 | PRECISION ONE LIFECARE; DETECTO; DETECTO | Precision One Lifecare, Ltd. | Sep 26, 2013 | SESE |
| K131394 | TRANSTEK GLASS BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | Sep 18, 2013 | SESE |
| K130311 | TRANSTEK BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | May 30, 2013 | SESE |
| K122388 | SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 | Seca GmbH & Co. KG | May 2, 2013 | SESE |
| K123228 | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) | Biospace Corporation Limited | Mar 8, 2013 | SESE |
| K123781 | TRANSTEK GLASS BODY FAT ANALYZER | Zhongshan Transtek Electronics Co., Ltd. | Jan 9, 2013 | SESE |
| K122976 | BODY FAT SCALE MODEL SF-371 | Shenzhen Belter Health Measurement and Analysis TE | Jan 4, 2013 | SESE |
| K121971 | WITHINGS, SMART BODY SCALE | Zhongshan Transtek Electronics Co., Ltd. | Sep 27, 2012 | SESE |
| K120896 | WI-FI BODY SCALE | Andon Health Co, Ltd. | Jul 26, 2012 | SESE |
| K121527 | WI-FI BODY SCALE | Shenzhen Healthcare Electronic Technology Co., Ltd. | Jun 28, 2012 | SESE |
| K112149 | WEIGHT AND BODY FAT SCALE SHINE BS0105 | Shine Overseas Marketing Limited | Apr 9, 2012 | SESE |
| K112951 | BODY ANALYSIS SCALE | Shenzhen Healthcare Electronic Technology Co., Ltd. | Nov 1, 2011 | SESE |
| K112932 | 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
