The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Otc Ems Stimulator.
| Device ID | K133965 |
| 510k Number | K133965 |
| Device Name: | OTC EMS STIMULATOR |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. No. 3 Building XiliBaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Contact | Qilian Liu |
| Correspondent | Qilian Liu SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. No. 3 Building XiliBaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-24 |
| Decision Date | 2014-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850003500161 | K133965 | 000 |