510(k) K252893
K252893 is an FDA 510(k) premarket notification submitted by Aneuvo for the device "ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)". The FDA issued a decision of Substantially Equivalent on Mar 27, 2026. The device falls under product code SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation), a Class II device regulated under 21 CFR 890.5851.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 2026
- Date Received
- Sep 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- Device Class
- Class II
- Regulation Number
- 890.5851
- Review Panel
- PM
- Submission Type
A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.