The following data is part of a premarket notification filed by Empi with the FDA for Infinity Electrotherapy System.
| Device ID | K042057 |
| 510k Number | K042057 |
| Device Name: | INFINITY ELECTROTHERAPY SYSTEM |
| Classification | Interferential Current Therapy |
| Applicant | EMPI 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane EMPI 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-30 |
| Decision Date | 2004-12-17 |
| Summary: | summary |