# K171092: XiniWave II Model ECS322P

- Pathway: 510(k) (Traditional)
- Applicant: International Trade Group, Inc.
- Decided: Jul 10, 2017 after 89 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K940301 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100441: Xiniwave, Model XW-18, International Trade Group, Inc. (2010) Summary page 5.

## Indications for use
TENS: The device is intended 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 exercise and/or normal household and work activities. NMS: The device is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K171092
Methodology: https://510kreport.com/methodology