K133872 is an FDA 510(k) clearance for the ARIA WIFI SMART SCALE, a Analyzer, Body Composition (Class II — Special Controls, product code MNW), submitted by Fitbit, Inc. (Fairfax, US). The FDA issued a Cleared decision on June 2, 2014, 164 days after receiving the submission on December 20, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K133872 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2013 |
| Decision Date | June 02, 2014 |
| Days to Decision | 164 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 |