Inbody AP1 Body Composition Analyzer
FDA 510(k) K023478 · Biospace Co.,Ltd
510(k) numberK023478
Submission
- Device name
- Inbody AP1 Body Composition Analyzer
- Applicant
- Biospace Co.,Ltd
Deer Field, IL, US - Received
- October 16, 2002
- Decision date
- May 13, 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 |
More from Guangdong Transtek Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K141483 | Biospace Body Composition AnalyzerMNW · Traditional | 09/23/2014SE |
| K130777 | InbodyMNW · Traditional | 11/25/2013SE |
| K131064 | BiospaceDXN · Traditional | 09/04/2013SE |
| K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/INBODY H20(B)MNW · Traditional | 03/08/2013SE |
| K110689 | InbodyMNW · Traditional | 08/19/2011SE |
| K092786 | Inbody, Models: 270, R20, R20BMNW · Traditional | 03/10/2010SE |
| K062603 | Biospace Body Composition Analyzers, Model Inbody 230MNW · Traditional | 02/15/2007SE |
| K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20MNW · Special | 12/16/2005SE |
| K042528 | Inbody, Model 3.0MNW · Traditional | 01/11/2005SE |
Questions and answers
When was Inbody AP1 Body Composition Analyzer cleared by the FDA?
Inbody AP1 Body Composition Analyzer (K023478) received a 510(k) decision of Substantially Equivalent on May 13, 2003, 209 days after the submission was received.
What is the product code of K023478?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.