Tanita Scale Plus Body Fat Monitor with Body Water Percentage
FDA 510(k) K040978 · Tanita Corp. of America
510(k) numberK040978
Submission
- Device name
- Tanita Scale Plus Body Fat Monitor with Body Water Percentage
- Applicant
- Tanita Corp. of America
Arlington Hgts., IL, US - Received
- April 15, 2004
- Decision date
- July 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)MNW · Traditional | 12/23/2004SE |
| K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418MNW · Traditional | 04/08/2004SE |
| K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleMNW · Traditional | 06/24/2002SE |
| K930599 | Body Fat Analyzer Model TBF-105DSB · Traditional | 11/01/1994SE |
| K932572 | Digital Baby Scale Model BLB-12FRW · Traditional | 11/16/1993SE |
Questions and answers
When was Tanita Scale Plus Body Fat Monitor with Body Water Percentage cleared by the FDA?
Tanita Scale Plus Body Fat Monitor with Body Water Percentage (K040978) received a 510(k) decision of Substantially Equivalent on July 22, 2004, 98 days after the submission was received.
What is the product code of K040978?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.