The following data is part of a premarket notification filed by Electric Mobility Corp. with the FDA for Electric Mobility Rascal.
Device ID | K924515 |
510k Number | K924515 |
Device Name: | ELECTRIC MOBILITY RASCAL |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | ELECTRIC MOBILITY CORP. #1 MOBILITY PLAZA Sewell, NJ 08080 |
Contact | Michael Flowers |
Correspondent | Michael Flowers ELECTRIC MOBILITY CORP. #1 MOBILITY PLAZA Sewell, NJ 08080 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-04 |
Decision Date | 1994-03-28 |