# K100441: Xiniwave, Model XW-18

- Pathway: 510(k) (Traditional)
- Applicant: International Trade Group, Inc.
- Decided: Jul 15, 2010 after 148 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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: 3 generations back to K940301 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060846: Therapeutic Massage Companion, Endurance Therapeutics (2007) Summary page 2.

## Most influential descendants
- K171092: XiniWave II Model ECS322P (2017), 0 descendants of its own

## Indications for use
A. TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/or normal non-commercial household work activities. B. NMS: The device is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K100441
Methodology: https://510kreport.com/methodology