Clearance Summary
STANDARD WHEELCHAIR PLATFORM received FDA 510(k) clearance under submission number K073565, sponsored by Design Specific , Ltd.. 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 2009-02-06.
- Submission: K073565
- Applicant / Sponsor: Design Specific , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3110
- Decision date: 2009-02-06
Classification & Regulation
This clearance is catalogued under FDA product code INO and 21 CFR 890.3110, within the Physical Medicine review panel as a Class II device.