# K043407: Inf 4160, Model D-FJ27F

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics Limited
- Decided: Feb 11, 2005 after 63 days
- Product code: LIH (Interferential Current Therapy)
- Device class: 2
- Regulation: 21 CFR 882.5890
- 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 K921441 (1992). 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)
- K952683: Apex Medical Corp. Portable Interferential Stimulation Device, Wholesale Medical Imports, Inc. (1997) Summary page 1.

## Indications for use
The INF 4160 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K043407
Methodology: https://510kreport.com/methodology