Thinner Resolve Fitness Monitor/Body Scale, Health-O-Meter
FDA 510(k) K010706 · Measurement Specialties, Inc.
510(k) numberK010706
Submission
- Device name
- Thinner Resolve Fitness Monitor/Body Scale, Health-O-Meter
- Applicant
- Measurement Specialties, Inc.
Lake Forest, CA, US - Received
- March 9, 2001
- Decision date
- October 5, 2001
- 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
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| 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 |
|---|---|---|
| K061191 | Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…DQA · Special | 05/22/2006SE |
Questions and answers
When was Thinner Resolve Fitness Monitor/Body Scale, Health-O-Meter cleared by the FDA?
Thinner Resolve Fitness Monitor/Body Scale, Health-O-Meter (K010706) received a 510(k) decision of Substantially Equivalent on October 5, 2001, 210 days after the submission was received.
What is the product code of K010706?
The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.