Impedimed - Body Composition Analysis
FDA 510(k) K050395 · Impedimed Pty , Ltd.
510(k) numberK050395
Submission
- Device name
- Impedimed - Body Composition Analysis
- Applicant
- Impedimed Pty , Ltd.
Brisbane, Queensland, AU - Received
- February 16, 2005
- Decision date
- July 13, 2005
- 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
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|---|---|---|---|
| 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 |
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| K230530 | SOZO ProOBH · Special | 05/04/2023SE |
| K203473 | SozoDSB · Traditional | 04/19/2021SE |
| K193410 | SOZO Body Fluid AnalyzerDSB · Traditional | 10/02/2020SE |
| K190529 | SozoQJB · Traditional | 11/25/2019SE |
| K180126 | SozoOBH · Traditional | 04/16/2018SE |
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Questions and answers
When was Impedimed - Body Composition Analysis cleared by the FDA?
Impedimed - Body Composition Analysis (K050395) received a 510(k) decision of Substantially Equivalent on July 13, 2005, 147 days after the submission was received.
What is the product code of K050395?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.