510(k) K101143
K101143 is an FDA 510(k) premarket notification submitted by Heartway Medical Products Co., Ltd. for the device "HEARTWAY POWER MOBILITY SCOOTER, S11". The FDA issued a decision of Substantially Equivalent on May 26, 2010. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Heartway Medical Products Co., Ltd. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2010
- Date Received
- Apr 22, 2010
- Clearance Type
- Traditional
- 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)