Device Classification Name |
wheelchair, standup
|
510(k) Number |
K191376 |
Device Name |
Modular Power Standing System |
Applicant |
Motion Concepts |
84 Citation Drive, Unit #1 |
Concord,
CA
L4K 3C1
|
|
Applicant Contact |
Dona Bhamra |
Correspondent |
Motion Concepts |
84 Citation Drive, Unit #1 |
Concord,
CA
L4K 3C1
|
|
Correspondent Contact |
Dona Bhamra |
Regulation Number | 890.3900
|
Classification Product Code |
|
Date Received | 05/23/2019 |
Decision Date | 08/13/2019 |
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
|
|
|