The following data is part of a premarket notification filed by Tung Fu Electric Co., Ltd. with the FDA for Tung Fu Airmate Tens, Vitality Mode, Tf-dt001.
| Device ID | K042107 |
| 510k Number | K042107 |
| Device Name: | TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | TUNG FU ELECTRIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min TUNG FU ELECTRIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-04 |
| Decision Date | 2005-03-09 |