FDA.reportPublic FDA data

ARC-EX System

Primary DI
08720908310033
Brand
ARC-EX System
Company
ONWARD Medical N.V.
Model
ARC-EX System - Personal US
Catalog number
EXSYS01PERUS
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And SensationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720908310033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720908310033087209083100338720908310033

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord rehabilitation transcutaneous electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of transcutaneous electrical stimulation to the spinal cord to improve or restore upper extremity sensory and motor function in adults with chronic neurological deficit resulting from incomplete spinal cord injury. It includes a portable electric current pulse generator and noninvasive electrodes. It is intended for use in the healthcare facility and in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (866) 217 0817support@onwd.com
+1 (617) 488 8642support@onwd.com

Regulatory Flags#

DUNS number
491823169
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720908310002ARC-EX SystemARC-EX System - Professional USEXSYS01PROUS2024-12-27
08720908310040ARC-EX SystemARC-EX System - Professional USEXSYS01PROUS2024-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053287404ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287411ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287428ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287442ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287459ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287466ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287473ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287480ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287497ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287503ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287510ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287541ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287268ExaStimNiche Biomedical, Inc.SDO2026-07-13
08720908310002ARC-EX SystemONWARD Medical N.V.SDO2024-12-27
08720908310040ARC-EX SystemONWARD Medical N.V.SDO2024-12-27