# K170903: Compex Wireless USA

- Pathway: 510(k) (Traditional)
- Applicant: Djo, LLC
- Decided: Jun 19, 2017 after 83 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: 6 generations back to K881114 (1988). 31 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143551: Compex Wireless USA, Djo, LLC (2015) Summary page 4.
- K153704: Strive, Djo, LLC (2016) Summary page 4.

## Most influential descendants
- K190966: Katalyst Training System (2020), 3 descendants of its own
- K181955: WiEMSpro (2019), 3 descendants of its own
- K212413: I-Motion (2022), 1 descendant of its own
- K233770: Pepper EMS Training System (2025), 0 descendants of its own
- K230261: Gnesis EMS Plus (2023), 0 descendants of its own

## Indications for use
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA 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 Compex Wireless USA may therefore be considered a technique of muscle training. The Compex Wireless USA TENS is used for: • temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. • the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Source page: https://510kreport.com/device/K170903
Methodology: https://510kreport.com/methodology