510(k) K142912
K142912 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "Merits Yoga Power Scooter, S542". The FDA issued a decision of Substantially Equivalent on June 23, 2015. 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
- June 23, 2015
- Date Received
- October 6, 2014
- Clearance Type
- Abbreviated
- 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