K120896 is an FDA 510(k) clearance for the WI-FI BODY SCALE. This device is classified as a Analyzer, Body Composition (Class II - Special Controls, product code MNW).
Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on July 26, 2012, 122 days after receiving the submission on March 26, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K120896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2012 |
| Decision Date | July 26, 2012 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MNW — Analyzer, Body Composition |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |