Clearance Summary
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 received FDA 510(k) clearance under submission number K011707, sponsored by Merits Medical Industries Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2001-08-03.
- Submission: K011707
- Applicant / Sponsor: Merits Medical Industries Co., Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2001-08-03
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.