The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Mt9000 Series Electro-stimulator, Models Mt9000, Mt9002, Mt9001, Mt9004 And Mt9003.
| Device ID | K093138 |
| 510k Number | K093138 |
| Device Name: | MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Contact | Zhigang Zhao |
| Correspondent | Zhigang Zhao SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2010-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80813520011939 | K093138 | 000 |
| 80092237616396 | K093138 | 000 |
| 80092237614675 | K093138 | 000 |
| 80092237614163 | K093138 | 000 |
| 80092237614156 | K093138 | 000 |
| 80092237614149 | K093138 | 000 |
| 80092237613739 | K093138 | 000 |
| 00092237600115 | K093138 | 000 |
| 80092237605819 | K093138 | 000 |
| 80092237616686 | K093138 | 000 |
| 80092237616693 | K093138 | 000 |
| 80092237616709 | K093138 | 000 |
| 80092237618796 | K093138 | 000 |
| 80092237618789 | K093138 | 000 |
| 80092237618772 | K093138 | 000 |
| 80092237618697 | K093138 | 000 |
| 80092237618604 | K093138 | 000 |
| 80092237618581 | K093138 | 000 |
| 80092237618536 | K093138 | 000 |
| 80092237618512 | K093138 | 000 |
| 00860000178303 | K093138 | 000 |