Clearance Summary
WITHINGS, SMART BODY SCALE received FDA 510(k) clearance under submission number K121971, sponsored by Zhongshan Transtek Electronics Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-09-27.
- Submission: K121971
- Applicant / Sponsor: Zhongshan Transtek Electronics Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2012-09-27
Classification & Regulation
This clearance is catalogued under FDA product code MNW and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.