Clearance Summary
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 received FDA 510(k) clearance under submission number K052008, 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 2005-09-16.
- Submission: K052008
- 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: 2005-09-16
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.