510(k) DEN240014
DEN240014 is an FDA 510(k) premarket notification submitted by Onward Medical, Inc. for the device "ARC-EX System". The FDA issued a decision of De Novo Granted on Dec 19, 2024. 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
- DENG (De Novo Granted)
- Decision Date
- Dec 19, 2024
- Date Received
- Mar 28, 2024
- Clearance Type
- Direct
- 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.