Axon Therapy
FDA 510(k) clearance K210021 · decided 2021-06-11
Clearance details
- K-number
- K210021
- Device name
- Axon Therapy
- Applicant
- Neuralace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-04
- Decision date
- 2021-06-11
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- QPL
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BTL-199 (K250309) | BTL Industries, Inc. | 2025-08-07 |
| Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (K250286) | The Magstim Company Limited | 2025-07-03 |
| StarFormer (M008-3T) (K241785) | Fotona D.O.O. | 2025-03-27 |
| Axon Therapy (K233364) | Neuralace Medical, Inc. | 2024-01-10 |
| MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (K230014) | Tonica Elektronik A/S | 2023-08-25 |
Recalls involving this device
No recalls on record reference this clearance.