Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body Analyzer;Transtek Glass Body Analyzer
FDA 510(k) K102191 · Zhongshan Transtek Electronics Co., Ltd.
510(k) numberK102191
Submission
- Device name
- Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body Analyzer;Transtek Glass Body Analyzer
- Applicant
- Zhongshan Transtek Electronics Co., Ltd.
Chengdu, Sichuan, CN - Received
- August 3, 2010
- Decision date
- May 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| K140045 | Body Composition AnalyzerMNW · Traditional | Jawon Medical Co., Ltd. | 02/18/2015SE |
| 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 |
More from Guangdong Transtek Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K123780 | Transtek Blood Pressure MonitorDXN · Special | 03/01/2013SE |
| K123781 | Transtek Glass Body Fat AnalyzerMNW · Special | 01/09/2013SE |
| K123669 | Transtek Wrist Blood Pressure MonitorDXN · Special | 12/21/2012SE |
| K122482 | Transtek Wrist Blood Pressure MonitorDXN · Abbreviated | 10/22/2012SE |
| K121971 | Withings, Smart Body ScaleMNW · Special | 09/27/2012SE |
| K120058 | Transtek Blood Pressure MonitorDXN · Special | 01/31/2012SE |
| K112932 | TranstekMNW · Special | 11/01/2011SE |
| K101681 | Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995DXN · Abbreviated | 05/27/2011SE |
Questions and answers
When was Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body Analyzer;Transtek Glass Body Analyzer cleared by the FDA?
Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body Analyzer;Transtek Glass Body Analyzer (K102191) received a 510(k) decision of Substantially Equivalent on May 2, 2011, 272 days after the submission was received.
What is the product code of K102191?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.