# K201975: miha bodytec II

- Pathway: 510(k) (Traditional)
- Applicant: Miha Bodytec GmbH
- Decided: Mar 11, 2021 after 238 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). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182519: Miha Bodytec II, Miha Bodytec GmbH (2019) Summary page 4.
- K090632: Compex Rehab, Chattanooga Group (2009) Summary page 4.

## Most influential descendants
- 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 (MBT 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. miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions: * Re-educating muscles * Relaxation of muscle spasm * Retarding or preventing disuse muscle atrophy The miha bodytec II electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations ofmotoneurons 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.

Source page: https://510kreport.com/device/K201975
Methodology: https://510kreport.com/methodology