510(k) K013788
K013788 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5". The FDA issued a decision of Substantially Equivalent on December 11, 2001. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Merits Health Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2001
- Date Received
- November 14, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vehicle, Motorized 3-Wheeled
- Device Class
- Class II
- Regulation Number
- 890.3800
- Review Panel
- PM
- Submission Type