The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Otc Electrical Stimulator (mt9001), Otc Tens Device (lt3060).
| Device ID | K130802 |
| 510k Number | K130802 |
| Device Name: | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Contact | Jianping Kang |
| Correspondent | Jianping Kang SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-22 |
| Decision Date | 2013-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817915020012 | K130802 | 000 |