The following data is part of a premarket notification filed by Empi with the FDA for Infinity Plus Electrotherapy System.
| Device ID | K041920 |
| 510k Number | K041920 |
| Device Name: | INFINITY PLUS ELECTROTHERAPY SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| 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 | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-16 |
| Decision Date | 2005-01-21 |
| Summary: | summary |