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 |