FDA.report

510(k) DEN240014

Device
ARC-EX System
Applicant
Onward Medical, Inc.
510(k) number
DEN240014
Product code
SDO
Decision
Unknown (DENG)
Decision date
2024-12-19
Date received
2024-03-28
Regulation
890.5851
Classification name
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Direct
Third party reviewed
N

Related Records

Applicant Contact

Contact
Nathalie Gilat
Address
50 Milk St. Boston MA US 02109 02109

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code SDO

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K253638xStep (xStep)Spinex, Inc.2026-04-20
K252893ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)Aneuvo2026-03-27
K251821ARC-EX SystemOnward Medical, Inc.2025-11-14