510(k) K251821
- Device
- ARC-EX System
- Applicant
- Onward Medical, Inc.
- 510(k) number
- K251821
- Product code
- SDO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-14
- Date received
- 2025-06-13
- Regulation
- 890.5851
- Classification name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Nathalie Gilat
- Address
- 50 Milk St. Boston MA US 02109 02109
FDA Registration Numbers
- 3034211447
- 3034209955
- 3027062639