# K991241: IF8000

- Pathway: 510(k) (Traditional)
- Applicant: Dan Med, Inc.
- Decided: Nov 2, 1999 after 204 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 25, 2009 · Class II · Z-1874-2014: Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.

## Indications for use
In Interferential Mode: Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. In NMES Mode: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent deep venous thrombosis. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K991241
Methodology: https://510kreport.com/methodology