510(k) K052522
- Device
- STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
- Applicant
- STAYHEALTHY, INC.
- 510(k) number
- K052522
- Product code
- MNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-13
- Date received
- 2005-09-14
- Regulation
- 870.2770
- Classification name
- Analyzer, Body Composition
- Medical specialty
- Cardiovascular
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLIN K HILL
- Address
- 300 Elfwood Dr. Monrovia CA US 91016 91016
FDA Registration Numbers#
- 3008262243
- 3007649409
- 3010844918
- 3005374248
- 3006624940
- 9680010
- 3005699942
- 1222304
- 3004782476
- 3003074886
- 3003193933
- 3009253624
- 3003741676
- 3008240972
- 3003587684
- 3017894657
- 3004485927
- 3004835896
- 3006026335
- 3003703880
- 3010288146
- 9616164
- 3008485370
- 3011065399
- 3005707783
- 3006570831
- 3006146787
- 8030245
- 3011191255
- 3015522053
- 3003695829
- 3010968402
- 3002684743
- 1450057
- 3006948217
- 3027717071
Source Documents#
Other 510(k) Records For Product Code MNW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231116 | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2024-06-15 |
| K140045 | BODY COMPOSITION ANALYZER | Jawon Medical Co., Ltd. | 2015-02-18 |
| K141483 | BIOSPACE BODY COMPOSITION ANALYZER | Biospace Corporation Limited | 2014-09-23 |
| K133872 | ARIA WIFI SMART SCALE | Fitbit, Inc. | 2014-06-02 |
| K140594 | BODY FAT ANALYZER AND SCALE | Conmo Electronic Company Limited | 2014-05-30 |
| K130777 | INBODY | Biospace Corporation Limited | 2013-11-25 |
| K130856 | BIA / VITALITY ANALYZER | Ipgdx, LLC | 2013-11-25 |
| K130952 | PRECISION ONE LIFECARE; DETECTO; DETECTO | Precision One Lifecare, Ltd. | 2013-09-26 |
| K131394 | TRANSTEK GLASS BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-09-18 |
| K130311 | TRANSTEK BODY FAT ANALYZER | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-05-30 |
| K122388 | SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 | Seca GmbH & Co. KG | 2013-05-02 |
| K123228 | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) | Biospace Corporation Limited | 2013-03-08 |
| K123781 | TRANSTEK GLASS BODY FAT ANALYZER | Zhongshan Transtek Electronics Co., Ltd. | 2013-01-09 |
| K122976 | BODY FAT SCALE MODEL SF-371 | Shenzhen Belter Health Measurement and Analysis TE | 2013-01-04 |
| K121971 | WITHINGS, SMART BODY SCALE | Zhongshan Transtek Electronics Co., Ltd. | 2012-09-27 |
Legacy Summary#
summary
FDA Review#
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