The following data is part of a premarket notification filed by Hong Qiang Xing (shenzhen) Electronics Limited with the FDA for Fit Belt.
| Device ID | K133108 |
| 510k Number | K133108 |
| Device Name: | FIT BELT |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED 4F.,JINGCHENG BUILDING, XICHENG INDUSTRIAL ZONE XIXIANG ROAD, BOA'AN DISTRICT Shenzhen, CN 518102 |
| Contact | Xu Jian Hua |
| Correspondent | Xu Jian Hua HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED 4F.,JINGCHENG BUILDING, XICHENG INDUSTRIAL ZONE XIXIANG ROAD, BOA'AN DISTRICT Shenzhen, CN 518102 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-08-05 |