# K233364: Axon Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Neuralace Medical, Inc.
- Decided: Jan 10, 2024 after 100 days
- Product code: QPL (Electromagnetic Stimulator, Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- 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 K984142 (1999). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210021: Axon Therapy, Neuralace Medical, Inc. (2021) Summary page 5.

## Most influential descendants
- K250309: BTL-199 (2025), 0 descendants of its own

## Indications for use
The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-traumatic pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on patients 18 and older.

Source page: https://510kreport.com/device/K233364
Methodology: https://510kreport.com/methodology