# K221498: Miha Bodytec II

- Pathway: 510(k) (Traditional)
- Applicant: Miha Bodytec GmbH
- Decided: Oct 7, 2022 after 137 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: 8 generations back to K881114 (1988). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201975: miha bodytec II, Miha Bodytec GmbH (2021) Summary page 4.
- K190966: Katalyst Training System, Katalyst, Inc. (2020) Summary page 4.

## Indications for use
miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. 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 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. miha bodytec II may only be used by persons above the age of 21.

Source page: https://510kreport.com/device/K221498
Methodology: https://510kreport.com/methodology