Clearance Summary
DEKA ARM SYSTEM received FDA 510(k) clearance under submission number DEN120016, sponsored by Deka Integrated Solutions Corporation. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2014-05-09.
- Submission: DEN120016
- Applicant / Sponsor: Deka Integrated Solutions Corporation
- Clearance pathway: Post-NSE
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3450
- Decision date: 2014-05-09
Classification & Regulation
This clearance is catalogued under FDA product code PAE and 21 CFR 890.3450, within the Physical Medicine review panel as a Class II device.