Clearance Summary
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER received FDA 510(k) clearance under submission number K031897, 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 2003-09-23.
- Submission: K031897
- Applicant / Sponsor: Imc-Heart Way LLC
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2003-09-23
Classification & Regulation
This clearance is catalogued under FDA product code INI and 21 CFR 890.3800, within the Physical Medicine review panel as a Class II device.