The following data is part of a premarket notification filed by Shian Jia Meei Enterprise Co., Ltd. with the FDA for Shian Jia Meei Digatal Pwn Tens, Model Yw-6000/uc-332/uc-330/st-331.
| Device ID | K040311 |
| 510k Number | K040311 |
| Device Name: | SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SHIAN JIA MEEI ENTERPRISE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaf, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich SHIAN JIA MEEI ENTERPRISE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaf, AZ 86001 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-10-01 |
| Summary: | summary |