510(k) K233364
K233364 is an FDA 510(k) premarket notification submitted by Neuralace Medical, Inc. for the device "Axon Therapy". The FDA issued a decision of Substantially Equivalent on January 10, 2024. The device falls under product code QPL (Electromagnetic Stimulator, Pain Relief), a Class II device regulated under 21 CFR 882.5890. Neuralace Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2024
- Date Received
- October 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromagnetic Stimulator, Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- PM
- Submission Type
Intended to apply a magnetic-field induced electrical current to treat pain.