ONWARD Medical N.V.

FDA Device Registration & Listing · Eindhoven Noord-Brabant, NL · Registration 3034211447

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3034211447
FEI Number
3034211447
Entity Name
ONWARD Medical N.V.
City/State/Country
Eindhoven Noord-Brabant, NL
Establishment Address
Schimmelt 2, Eindhoven Noord-Brabant 5611 ZX, NL
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Onward Medical (Owner Number: 10092025)
Owner / Operator Contact Address
50 Milk Street, Boston, MA 02109, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251821
PMA Number
N/A

All Registered Proprietary Names

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 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
3034209955 ONWARD Medical S.A. Lausanne Vaud, CH
3027062639 ONWARD Medical Inc. Boston, MA, US

Similar Registrations

Registration Number Establishment Name Location
3034209955 ONWARD Medical S.A. Lausanne Vaud, CH
3027062639 ONWARD Medical Inc. Boston, MA, US
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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 3034211447. Last updated year: 2026. Please use registration number 3034211447 when referencing this establishment in official correspondence.
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