510(k) K853918
K853918 is an FDA 510(k) premarket notification submitted by Amigo Sales, Inc. for the device "THE SPORTSTER (ELECTRIFIED WHEELCHAIR)". The FDA issued a decision of Substantially Equivalent on January 13, 1986. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Amigo Sales, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1986
- Date Received
- September 23, 1985
- 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