# K121338: ZEOBI

- Pathway: 510(k) (Special)
- Applicant: Ivivi Health Science, LLC
- Decided: Jul 27, 2012 after 85 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: 2 generations back to K903675 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070541: Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II, Ivivi Technologies, Inc. (2008) Summary page 5.

## 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/K121338
Methodology: https://510kreport.com/methodology