Data / Medical devices / United States / ONWARD Medical Inc.
ONWARD Medical Inc.: FDA-registered device maker in Boston, MA, United States, 1 510(k) clearance
ONWARD Medical Inc. is registered with the FDA (registration 3027062639) in Boston, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027062639
- Address
- 50 Milk St, Boston, MA, United States, 02109
- Owner or operator
- Onward Medical (10092025)
- Roles
- Complaint file establishment
- First device listed
- December 3, 2025
- Registered through
- 2027
- Brand names listed
- ARC-EX System, ARC-EX System - Personal, ARC-EX System - Professional
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | SDO | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 14, 2025 | K251821 | ARC-EX System | SDO | Substantially Equivalent | Onward Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.