# K133225: E-Fit EF-1280 Ems Machine

- Pathway: 510(k) (Traditional)
- Applicant: Fit-Pro Kft, Ltd.
- Decided: Oct 24, 2014 after 368 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: 2 generations back to K940301 (1994). 2 ancestors in all.
19 later devices descend from it; 7 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011880: Compex Sport, Compex S.A. (2002) Summary page 4.

## Most influential descendants
- K190038: Xbody Newave USA (2019), 4 descendants of its own
- K221200: XBody Go USA, XBody Pro USA (2023), 3 descendants of its own
- K182519: Miha Bodytec II (2019), 3 descendants of its own
- K181955: WiEMSpro (2019), 3 descendants of its own
- K201975: miha bodytec II (2021), 2 descendants of its own

## Indications for use
E‐Fit EF‐1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. The E‐Fit EF‐1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The E‐Fit EF‐1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E‐Fit EF‐1280 training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

Source page: https://510kreport.com/device/K133225
Methodology: https://510kreport.com/methodology