Device Classification Name |
vehicle, motorized 3-wheeled |
|||
---|---|---|---|---|
510(k) Number | K991132 | |||
Device Name | ACTIVA | |||
Applicant |
|
|||
Applicant Contact | stan cooper | |||
Correspondent |
|
|||
Correspodent Contact | stan cooper | |||
Regulation Number | 890.3800 | |||
Classification Product Code |
|
|||
Date Received | 04/02/1999 | |||
Decision Date | 10/20/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Physical Medicine |
|||
510k Review Panel |
Neurology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |