Smartshape Body Composition Analyzer, Model 4010
FDA 510(k) K023817 · Clio Designs, Inc.
510(k) numberK023817
Submission
- Device name
- Smartshape Body Composition Analyzer, Model 4010
- Applicant
- Clio Designs, Inc.
Watertown, MA, US - Received
- November 15, 2002
- Decision date
- June 25, 2003
- 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 |
| 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 |
Questions and answers
When was Smartshape Body Composition Analyzer, Model 4010 cleared by the FDA?
Smartshape Body Composition Analyzer, Model 4010 (K023817) received a 510(k) decision of Substantially Equivalent on June 25, 2003, 222 days after the submission was received.
What is the product code of K023817?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.