Device Classification Name |
Vehicle, Motorized 3-Wheeled
|
510(k) Number |
K926499 |
Device Name |
SHUTTLE SC-140 |
Applicant |
PRIDE HEALTH CARE, INC. |
71 S. MAIN ST. |
PITTSTON,
PA
18640
|
|
Applicant Contact |
THOMAS KRETCHIK |
Correspondent |
PRIDE HEALTH CARE, INC. |
71 S. MAIN ST. |
PITTSTON,
PA
18640
|
|
Correspondent Contact |
THOMAS KRETCHIK |
Regulation Number | 890.3800
|
Classification Product Code |
|
Date Received | 12/29/1992 |
Decision Date | 03/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|