510(k) K011753
K011753 is an FDA 510(k) premarket notification submitted by Merits Health Products., Inc. for the device "TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4". The FDA issued a decision of Substantially Equivalent on Aug 3, 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., Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2001
- Date Received
- Jun 6, 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
- 510(k)