# K111557: X-Force

- Pathway: 510(k) (Traditional)
- Applicant: Seven Seas Distribtion and Manufacturing, LLC
- Decided: Nov 10, 2011 after 160 days
- Product code: NYN (Stimulator, Electrical, Transcutaneous, For Arthritis)
- 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: 4 generations back to K971437 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073386: Joint Stim, Model 1000, Pain Management Technologies (2008) Summary page 3.

## Indications for use
The N-Force external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee. The N-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the Hand.

Source page: https://510kreport.com/device/K111557
Methodology: https://510kreport.com/methodology