# K182519: Miha Bodytec II

- Pathway: 510(k) (Traditional)
- Applicant: Miha Bodytec GmbH
- Decided: Jun 7, 2019 after 267 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.
3 later devices descend 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)
- K133225: E-Fit EF-1280 Ems Machine, Fit-Pro Kft, Ltd. (2014) Summary page 4.

## Most influential descendants
- K201975: miha bodytec II (2021), 2 descendants of its own
- K223797: Neuro20 Pro System (2023), 0 descendants of its own
- K221498: Miha Bodytec II (2022), 0 descendants of its own

## Indications for use
miha bodytec II 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 healthy muscles and clients, not be used for rehabilitation purposes. miha bodytec II is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. miha bodytec II is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the miha bodytec II training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated. The miha bodytec II 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 miha bodytec II can impose on the stimulated muscles are able to improve or facilitate muscle performance. The miha bodytec II may therefore be considered a technique of muscle training.

Source page: https://510kreport.com/device/K182519
Methodology: https://510kreport.com/methodology