The following data is part of a premarket notification filed by Ivivi Technologies, Inc. with the FDA for Ivivi Sofpulse, Models 912-m10, Roma3 And Torino Ii.
| Device ID | K070541 |
| 510k Number | K070541 |
| Device Name: | IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | IVIVI TECHNOLOGIES, INC. 224 PEGASUS AVE. Northvale, NJ 07647 |
| Contact | Andre Dimino |
| Correspondent | Andre Dimino IVIVI TECHNOLOGIES, INC. 224 PEGASUS AVE. Northvale, NJ 07647 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-26 |
| Decision Date | 2008-12-11 |
| Summary: | summary |