Clearance Summary
SYSTEM-ARMS, MODELS 390, X60 received FDA 510(k) clearance under submission number K083164, sponsored by Bio-Medical Research, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2008-12-16.
- Submission: K083164
- Applicant / Sponsor: Bio-Medical Research, Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2008-12-16
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.