# K011880: Compex Sport

- Pathway: 510(k) (Traditional)
- Applicant: Compex S.A.
- Decided: Apr 17, 2002 after 306 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: 1 generation back to K940301 (1994). 1 ancestor in all.
195 later devices descend from it; 12 cite it directly.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940301: Compex 2, Biodex Medical Systems, Inc. (1994) Summary page 2.

## Most influential descendants
- K060846: Therapeutic Massage Companion (2007), 151 descendants of its own
- K102598: HI-Dow-XP (2011), 78 descendants of its own
- K112392: Hivox Biotek Inc. (2012), 58 descendants of its own
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), 55 descendants of its own
- K110068: Model PM3030 (2011), 50 descendants of its own

## Indications for use
"Compex® Sport" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. "Compex® Sport" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "Compex® Sport" training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The "Compex® Sport" electrical impulses allow triggering 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 "Compex® Sport” can impose on the stimulated muscles are able to improve or facilitate muscle performance. "Compex® Sport" may therefore be considered a technique of muscle training.

Source page: https://510kreport.com/device/K011880
Methodology: https://510kreport.com/methodology