Electric Mobility Rascal and Chauffer Scooters
by Electric Mobility Corp. 510(k)
Active
510(k) K002616
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002616 | Date11 Dec 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0416-2011
- Terminated Z-0417-2011
- Terminated Z-0415-2011
Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in complete failure of the seat base, causing the user to fall off the vehicle.
-
- Terminated Z-0903-06
The four seat mast mounting screws can loosen, causing seat to wobble. The chair seat actuator and portions of the seat can malfunction and/or break. Firm is aware of problems with the seat and injuries sustained from the powered wheelchair/scooter seat malfunction. Firm has not initiated recall, claims it is a Warranty Advisory.
Specification
- 510(k) Number
- FDA Product Code
- INI
- FDA applicant
- Electric Mobility, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent