# K202148: E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)

- Pathway: 510(k) (Traditional)
- Applicant: Fit-Pro, Ltd.
- Decided: Aug 25, 2021 after 387 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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
- K260945: Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) (2026), 0 descendants of its own

## Indications for use
The E-Fit Infinity System is designated to prescription use (Rx) only. E-Fit Infinity system (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes. The E-Fit Infinity system was designed to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit Infinity system must not be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit Infinity system training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The E-Fit Infinity system's electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones 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 E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training.

Source page: https://510kreport.com/device/K202148
Methodology: https://510kreport.com/methodology