Axon Therapy
FDA 510(k) K210021 · Neuralace Medical, Inc.
510(k) numberK210021
Submission
- Device name
- Axon Therapy
- Applicant
- Neuralace Medical, Inc.
San Diego, CA, US - Received
- January 4, 2021
- Decision date
- June 11, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code QPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250309 | BTL-199QPL · Traditional | BTL Industries, Inc. | 08/07/2025SE |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…QPL · Traditional | The Magstim Company Limited | 07/03/2025SE |
| K241785 | StarFormer (M008-3T)QPL · Traditional | Fotona D.O.O. | 03/27/2025SE |
| K233364 | Axon TherapyQPL · Traditional | Neuralace Medical, Inc. | 01/10/2024SE |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…QPL · Traditional | Tonica Elektronik A/S | 08/25/2023SE |
More from Tonica Elektronik A/S
| 510(k) | Device | Decision |
|---|---|---|
| K233364 | Axon TherapyQPL · Traditional | 01/10/2024SE |
Questions and answers
When was Axon Therapy cleared by the FDA?
Axon Therapy (K210021) received a 510(k) decision of Substantially Equivalent on June 11, 2021, 158 days after the submission was received.
What is the product code of K210021?
The FDA product code is QPL – Electromagnetic Stimulator, Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.