Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034209955

FEI Number

3034209955

Entity Name

ONWARD Medical S.A.

City/State/Country

Lausanne Vaud, CH

Establishment Address

Pont de Bessieres 3, Lausanne Vaud 1005, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Onward Medical (Owner Number: 10092025)

Owner / Operator Contact Address

50 Milk Street, Boston, MA 02109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARC-EX System - Professional US ARC-EX System - Personal ARC-EX System - Professional ARC-EX System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SDO	Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation	Physical Medicine	Class 2	890.5851	2024-12-20
SDO	Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation	Physical Medicine	Class 2	890.5851	2025-12-03

Official Correspondent

Nathalie Gilat

US Agent Details

Nathalie Gilat Business: ONWARD Medical Inc. Email: nathalie.gilat@onwd.com Phone: (585) 3639124

Related Public Records

Same Entity

Onward Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034211447	ONWARD Medical N.V.	Eindhoven Noord-Brabant, NL
3027062639	ONWARD Medical Inc.	Boston, MA, US

Similar Registrations

Registration Number	Establishment Name	Location
3034211447	ONWARD Medical N.V.	Eindhoven Noord-Brabant, NL
3027062639	ONWARD Medical Inc.	Boston, MA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034209955. Last updated year: 2026. Please use registration number 3034209955 when referencing this establishment in official correspondence.