Clearance Summary
IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) received FDA 510(k) clearance under submission number K063475, sponsored by Imc-Heart Way LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2007-01-23.
- Submission: K063475
- Applicant / Sponsor: Imc-Heart Way LLC
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2007-01-23
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.