510(k) K251821
K251821 is an FDA 510(k) premarket notification submitted by Onward Medical, Inc. for the device "ARC-EX System". The FDA issued a decision of Substantially Equivalent on Nov 14, 2025. 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. Onward Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 14, 2025
- Date Received
- Jun 13, 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.