# K070541: Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II

- Pathway: 510(k) (Traditional)
- Applicant: Ivivi Technologies, Inc.
- Decided: Dec 11, 2008 after 654 days
- Product code: ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903675 (1991). 1 ancestor in all.
8 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903675: Magnetic Resonance Therapy Device, Mrt, Inc. (1991) Summary page 5.

## Most influential descendants
- K092044: Orthocor Knee System, Median, Large, X-Large (2009), 3 descendants of its own
- K091996: Orthocor Knee System Basic (2009), 2 descendants of its own
- K152432: ActiPatch (R) (2017), 1 descendant of its own
- K121702: Orthocor Active Device Orthocor General Use Active Device (2013), 1 descendant of its own
- K241395: Active System; Avenue8 (2024), 0 descendants of its own

## Indications for use
Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

Source page: https://510kreport.com/device/K070541
Methodology: https://510kreport.com/methodology