The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Care Back Pain Relief Stimulator; Care Back Pain Relief Stimulator.
| Device ID | K110707 |
| 510k Number | K110707 |
| Device Name: | CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. NO. 3 BUILDING, XILIYIANGGUANG INDUSTRIAL ESTATE XILXIAOBAIMA Shenzhen Guangdong, CN 518108 |
| Contact | Kang Jian Ping |
| Correspondent | Kang Jian Ping SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. NO. 3 BUILDING, XILIYIANGGUANG INDUSTRIAL ESTATE XILXIAOBAIMA 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 | 2011-03-14 |
| Decision Date | 2011-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80092237605451 | K110707 | 000 |