The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Dx6605e-tens, Dx6605e-g, Dx6609-g.
| Device ID | K082057 |
| 510k Number | K082057 |
| Device Name: | DX6605E-TENS, DX6605E-G, DX6609-G |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. FANSHENXUSHENG INDUSTRIAL ESTATE Shenzhen, Bao'an District, CN 518108 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-21 |
| Decision Date | 2009-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80092237616716 | K082057 | 000 |