# K201653: Compex Sport Elite 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Djo, LLC
- Decided: Nov 27, 2020 after 162 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: 7 generations back to K881114 (1988). 31 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170918: Compex Sport Elite, Djo, LLC (2017) Summary page 4.

## Most influential descendants
- K253636: Zionic Pro Max (EMS) (2026), 0 descendants of its own
- K252154: Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) (2025), 0 descendants of its own

## Indications for use
EMS: The Compex Sport Elite 3.0 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex Sport Elite 3.0 programs is not suitable for rehabilitation or physiotherapy. TENS: The Compex Sport Elite 3.0 TENS is intended 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. The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.

Source page: https://510kreport.com/device/K201653
Methodology: https://510kreport.com/methodology