Device Classification Name |
Wheelchair, Powered
|
510(k) Number |
K955548 |
Device Name |
CHIPS POWERED WHEELCHAIR |
Applicant |
INTERNATIONAL HEALTHCARE SOLUTIONS, INC. |
368 W. VETERANS HIGHWAY |
COMMACK,
NY
11725
|
|
Applicant Contact |
FRED DI VITO |
Correspondent |
INTERNATIONAL HEALTHCARE SOLUTIONS, INC. |
368 W. VETERANS HIGHWAY |
COMMACK,
NY
11725
|
|
Correspondent Contact |
FRED DI VITO |
Regulation Number | 890.3860 |
Classification Product Code |
|
Date Received | 12/05/1995 |
Decision Date | 09/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|