# K160246: SimulCare II (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Xanacare Technologies, LLC
- Decided: Oct 6, 2016 after 248 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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: 7 generations back to K001179 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083202: Combocare 2000, Xanacare Technologies, LLC (2008) Summary page 4.
- K081141: Combocare 2000, Xanacare Technologies, LLC (2008) Summary page 4.

## Indications for use
The SimulCare II™ is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic pain.

Source page: https://510kreport.com/device/K160246
Methodology: https://510kreport.com/methodology