# K210021: Axon Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Neuralace Medical, Inc.
- Decided: Jun 11, 2021 after 158 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: 5 generations back to K984142 (1999). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181688: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator, Shenzhen Roundwhale Technology Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K230014: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (2023), 3 descendants of its own
- K233364: Axon Therapy (2024), 1 descendant of its own
- K250309: BTL-199 (2025), 0 descendants of its own
- K250286: Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (2025), 0 descendants of its own
- K241785: StarFormer (M008-3T) (2025), 0 descendants of its own

## Indications for use
The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 and older.

Source page: https://510kreport.com/device/K210021
Methodology: https://510kreport.com/methodology