# K190038: Xbody Newave USA

- Pathway: 510(k) (Traditional)
- Applicant: Xbody Hungary Kft.
- Decided: Apr 5, 2019 after 87 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: 3 generations back to K940301 (1994). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133225: E-Fit EF-1280 Ems Machine, Fit-Pro Kft, Ltd. (2014) Summary page 4.

## Most influential descendants
- K221200: XBody Go USA, XBody Pro USA (2023), 3 descendants of its own
- K250146: SofWave System (2025), 1 descendant of its own
- K251746: Pure Impact (2025), 0 descendants of its own
- K242926: XBody Go USA, XBody Pro USA (2025), 0 descendants of its own

## Indications for use
The XBODY NEWAVE USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and people (clients), not for rehabilitation purposes. The XBODY NEWAVE USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBODY NEWAVE USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY NEWAVE USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The XBODY NEWAVE USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the XBODY NEWAVE USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY NEWAVE USA may therefore be considered a technique of muscle training.

Source page: https://510kreport.com/device/K190038
Methodology: https://510kreport.com/methodology