Clearance Summary
DUET BICYCLE/WHEELCHAIR received FDA 510(k) clearance under submission number K913759, sponsored by Robert Hoening Mobility Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1991-10-24.
- Submission: K913759
- Applicant / Sponsor: Robert Hoening Mobility Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1991-10-24
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.