FDA Registration
Active
🇨🇭 Switzerland
ARC-EX System - Professional US
Reg #: 3034209955
·
FEI: 3034209955
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ONWARD Medical S.A.
- Registration Number
- 3034209955
- FEI Number
- 3034209955
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Pont de Bessieres 3
- City
- Lausanne Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- DEN240014
Owner / Operator
- Firm Name
- Onward Medical
- Operator Number
- 10092025
- Address
- 50 Milk Street
- City
- Boston
- State
- MA
- Postal Code
- 02109
- Country
- US
- Correspondent
- Nathalie Gilat
US Agent
- Business Name
- ONWARD Medical Inc.
- Contact Name
- Nathalie Gilat
- Address
- 50 Milk St
- City
- Boston
- State
- MA
- ZIP
- 02109
- Country
- US
- [email protected]
- Phone
- 585 3639124
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | SDO | Class 2 | Physical Medicine | No | 2024-12-20 |
Proprietary Names
ARC-EX System - Professional US
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)