Clearance Summary
ORION II (HEAVY DUTY 350 LBS AND 500 LBS) received FDA 510(k) clearance under submission number K101277, sponsored by Future Mobility Healthcare, Inc.. 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 2010-06-04.
- Submission: K101277
- Applicant / Sponsor: Future Mobility Healthcare, Inc.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2010-06-04
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.