The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Hepax (tens).
| Device ID | K882154 |
| 510k Number | K882154 |
| Device Name: | HEPAX (TENS) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell, GA 30076 -4807 |
| Contact | Alfred Marek |
| Correspondent | Alfred Marek AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell, GA 30076 -4807 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-23 |
| Decision Date | 1988-09-30 |