The following data is part of a premarket notification filed by Roc Chinese-european Industrial Research Society with the FDA for Sanidad Health-up Tens Mp-73725.
| Device ID | K014126 |
| 510k Number | K014126 |
| Device Name: | SANIDAD HEALTH-UP TENS MP-73725 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO.58, FU-CHIUN STREET, Hsin-chu City, TW |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO.58, FU-CHIUN STREET, Hsin-chu City, TW |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-17 |
| Decision Date | 2002-05-03 |