The following data is part of a premarket notification filed by Shian Jia Meei Enterprise Co., Ltd. with the FDA for Shian Jia Meei Two Channel Digital T.e.n.s..
| Device ID | K052182 |
| 510k Number | K052182 |
| Device Name: | SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S. |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SHIAN JIA MEEI ENTERPRISE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich SHIAN JIA MEEI ENTERPRISE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, 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 | 2005-08-10 |
| Decision Date | 2005-11-04 |
| Summary: | summary |