The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Transcutaneous Electrical Nerve Stimulator Se-30 Tens.
| Device ID | K991397 |
| 510k Number | K991397 |
| Device Name: | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SEIN ELECTRONICS CO., LTD. 1540 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Contact | S.h. Hwang |
| Correspondent | S.h. Hwang SEIN ELECTRONICS CO., LTD. 1540 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 2000-02-11 |
| Summary: | summary |