The following data is part of a premarket notification filed by Zhongshan Transtek Electronics Co., Ltd. with the FDA for Withings, Smart Body Scale.
| Device ID | K121971 |
| 510k Number | K121971 |
| Device Name: | WITHINGS, SMART BODY SCALE |
| Classification | Analyzer, Body Composition |
| Applicant | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
| Contact | Leo Wang |
| Correspondent | Leo Wang ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. NO. 1 FANGHUA STREET HI-TECH DISTRICT Chengdu, Sichuan, CN 610041 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-05 |
| Decision Date | 2012-09-27 |
| Summary: | summary |