Device Classification Name |
wheelchair, powered
|
510(k) Number |
K021199 |
Device Name |
PRIMECHAIR |
Applicant |
DALTON MEDICAL CORP. |
1103 VENTURE CT. |
CARROLLTON,
TX
75006
|
|
Applicant Contact |
WILL RIDGWAY |
Correspondent |
DALTON MEDICAL CORP. |
1103 VENTURE CT. |
CARROLLTON,
TX
75006
|
|
Correspondent Contact |
WILL RIDGWAY |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 04/16/2002 |
Decision Date | 07/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|